Sun Pharmaceutical Industries Inc.

FDA Drug Class II Ongoing

Diclofenac Sodium, Topical Gel, 3%, 100 g tube, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 516

January 27, 2026 Sun Pharmaceutical Industries Inc. N/A units

FDA Drug Class III Ongoing

Fluocinolone Acetonide Solution Topical Solution USP, 0.01%, 60-mL bottles, Rx only, Dist. by: Taro Pharmaceuticals Inc., Hawthorn, NY 10532. NDC 51672-1365-4

December 30, 2025 Sun Pharmaceutical Industries Inc. 24,624 bottles units

FDA Drug Class III Ongoing

Clindamycin Phosphate USP, 1% (10 mg/mL), Topical Solution, 60 mL per applicator bottle, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel; Dist. by: Taro Pharmaceuticals USA, I

November 26, 2025 Sun Pharmaceutical Industries Inc.

FDA Drug Class II Ongoing

Lisdexamfetamine Dimesylate Capsules, 30 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury,

October 28, 2025 Sun Pharmaceutical Industries Inc. N/A units

FDA Drug Class II Ongoing

Lisdexamfetamine Dimesylate Capsules, 40 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury,

October 28, 2025 Sun Pharmaceutical Industries Inc. N/A units

FDA Drug Class II Ongoing

Lisdexamfetamine Dimesylate Capsules, 10 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury,

October 28, 2025 Sun Pharmaceutical Industries Inc. N/A units

FDA Drug Class II Ongoing

Lisdexamfetamine Dimesylate Capsules, 20 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury,

October 28, 2025 Sun Pharmaceutical Industries Inc. N/A units

FDA Drug Class II Ongoing

Lisdexamfetamine Dimesylate Capsules, 70 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury,

October 28, 2025 Sun Pharmaceutical Industries Inc. N/A units

FDA Drug Class II Ongoing

Lisdexamfetamine Dimesylate Capsules, 50 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury,

October 28, 2025 Sun Pharmaceutical Industries Inc. N/A units

FDA Drug Class II Ongoing

Lisdexamfetamine Dimesylate Capsules, 60 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury,

October 28, 2025 Sun Pharmaceutical Industries Inc. N/A units

FDA Drug Class II Ongoing

Kit for the Preparation of Technetium Tc 99m Mertiatide, Rx Only, Manufactured by: Sun Pharmaceutical Industries, Inc. Billerica, MA 01821, NDC 45567-0655-1

September 3, 2025 Sun Pharmaceutical Industries Inc. 1870 kits units

FDA Drug Class II Ongoing

Spironolactone Tablets, USP, 25 mg, 100-count bottle, Rx only, Mfg. by: Frontida BioPharm, Inc., 1100 Orthodox St, Philadelphia, PA 19124, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 0

August 5, 2025 Sun Pharmaceutical Industries Inc. 11,328 bottles units

FDA Drug Class II Ongoing

Lisdexamfetamine Dimesylate Capsules, 60 mg, CII, 100-count bottles, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceuticals, Inc., Cranbury, NJ 08512,

June 16, 2025 Sun Pharmaceutical Industries Inc. 5,448 bottles units

FDA Drug Class III Ongoing

Gabapentin Capsules, USP 300 mg, Rx Only, Packaged in a) 500-count bottles, NDC 62756-138-05; b) 1000-count bottles, NDC 62756-138-04, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ

March 4, 2025 Sun Pharmaceutical Industries Inc. 12,876 bottles units

FDA Drug Class III Ongoing

Gabapentin Capsules, USP 400 mg, Rx Only, Packaged in a) 500-count bottles, NDC 62756-139-05; b) 1000-count bottles, NDC 62756-139-04; Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ

March 4, 2025 Sun Pharmaceutical Industries Inc. 852 bottles units

FDA Drug Class II Ongoing

Morphine Sulfate Extended-Release Tablets, 100 mg, 100-count bottles, Rx Only, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901. Distributed by: Sun Pharmaceutical Industries, Inc., Cr

February 6, 2025 Sun Pharmaceutical Industries Inc. 9840 bottles units

FDA Drug Class II Terminated

Nitrofurantoin Capsules, USP (Macrocrystals), 100 mg, Rx Only, 100 capsules per bottle, Manufactured by: Sidmak Laboratories (India) Pvt. Ltd. Plot No. 20, Pharmacity, Selaqui Industrial Area, Dehradu

July 9, 2024 Sun Pharmaceutical Industries Inc. 5752 bottles units

FDA Drug Class II Ongoing

Decitabine for Injection 50mg per vial, For intravenous infusion only Cytotoxic Agent, Sterile, Rx Only, Single-Dose Vial, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manu

July 2, 2024 Sun Pharmaceutical Industries Inc. 2088 vials units

FDA Drug Class III Ongoing

Xelpros (latanoprost ophthalmic emulsion) 0.005%, 125mcg/2.5mL, 2.5 mL bottle, Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., India., NDC 47335-317-90

April 22, 2024 Sun Pharmaceutical Industries Inc. 35,069 bottles units

FDA Drug Class II Ongoing

Amphotericin B Liposome for Injection, 50mg vials, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Medicare Limited, Baska Ujeti Ro

April 19, 2024 Sun Pharmaceutical Industries Inc. 11,016 vials units

FDA Drug Class II Ongoing

Febuxostat Tablets 40mg, RX Only, 30 Tablets per bottle, NorthStarx, Manufactured for: Northstar Rx LLC., Memphis, TN 38141 , Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 259/15,

March 4, 2024 Sun Pharmaceutical Industries Inc. 47,520 bottles units

FDA Drug Class II Ongoing

Febuxostat Tablets 80mg, RX Only, 30 Tablets per bottle, NorthStarx, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 259/15, D

March 4, 2024 Sun Pharmaceutical Industries Inc. 7,488 bottles units

FDA Drug Class II Ongoing

Mesalamine Extended-Release Capsules, USP 500mg, Rx Only, 120 Capsules per bottle, Manufactured by: Sun Pharmaceutical Industries Limited, Mohali, INDIA, Distributed by: Sun Pharmaceutical Industries,

February 5, 2024 Sun Pharmaceutical Industries Inc. 54,960 bottles units

FDA Drug Class II Completed

Fexofenadine Hydrochloride Tablets, USP 180mg, Antihistamine, Allergy, 24 hour, a) 30 Tablets per bottle, NDC 51660-998-30; Distributed by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Made in Indi

January 18, 2024 Sun Pharmaceutical Industries Inc. 54,504 bottles units

FDA Drug Class II Completed

Zolpidem Tartrate Extended-Release Tablets, USP 6.25 mg, Rx Only, 100 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical I

January 18, 2024 Sun Pharmaceutical Industries Inc. 1220 bottles units

FDA Drug Class II Completed

Febuxostat Tablets 40mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15

January 18, 2024 Sun Pharmaceutical Industries Inc. 55,272 bottles units

FDA Drug Class II Completed

Febuxostat Tablets 80 mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/1

January 18, 2024 Sun Pharmaceutical Industries Inc. 19,992 bottles units

FDA Drug Class II Completed

Niacin Extended-Release Tablets, USP 1000mg, Rx Only, 90 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Lim

January 18, 2024 Sun Pharmaceutical Industries Inc. 6552 bottles units

FDA Drug Class II Completed

Niacin Extended-Release Tablets, USP 500mg, Rx Only, 90 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limi

January 18, 2024 Sun Pharmaceutical Industries Inc. 15,768 bottles units

FDA Drug Class II Completed

Lurasidone Hydrochloride Tablets 120mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., S

January 18, 2024 Sun Pharmaceutical Industries Inc. 9,408 bottles units

FDA Drug Class II Completed

Cinacalcet Tablets 60mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 259/

January 18, 2024 Sun Pharmaceutical Industries Inc. 1,728 bottles units

FDA Drug Class II Completed

Mesalamine Delayed-Release Tablets, USP 1.2 g per tablet, Rx Only, 120 Tablets per bottle, Once Daily, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pha

January 18, 2024 Sun Pharmaceutical Industries Inc. 10,690 bottles units

FDA Drug Class II Completed

Zolpidem Tartrate Extended-Release Tablets, USP 12.5mg, Rx Only, 100 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical In

January 18, 2024 Sun Pharmaceutical Industries Inc. 14,568 bottles units

FDA Drug Class II Completed

Lurasidone Hydrochloride Tablets 60mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Su

January 18, 2024 Sun Pharmaceutical Industries Inc. 11,400 bottles units

FDA Drug Class II Terminated

Liothyronine Sodium Tablets, USP 5 mcg, 100-count bottle, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured by: Sun Pharmaceutical Industries Ltd. Survey No.

December 4, 2023 Sun Pharmaceutical Industries Inc. 96,192 bottles units

FDA Drug Class III Terminated

buPROPion Hydrochloride Extended-Release Tablets, USP (SR) 200 mg, 60 Tablets bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Indus

November 22, 2023 Sun Pharmaceutical Industries Inc. 2016 Bottles units

FDA Drug Class II Terminated

Liothyronine Sodium Tablets, USP, 25 mcg, 100-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc.Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd. Survey

October 20, 2023 Sun Pharmaceutical Industries Inc. 2304 Bottles units

FDA Drug Class II Terminated

Liothyronine Sodium Tablets, USP, 5 mcg, 100-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc.Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd. Survey N

October 20, 2023 Sun Pharmaceutical Industries Inc. 7392 Bottles units

FDA Drug Class III Terminated

Bupropion Hydrochloride Extended-Release Tablets USP (SR), 150 mg, 60 tablets bottle, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutic

October 4, 2023 Sun Pharmaceutical Industries Inc. 144 bottles units

FDA Drug Class III Terminated

Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouches x 10 single-use vials (0.25 mL each)), Rx only, Manufactured for Sun Pharma Global FZE by: Laboratoire Unither, Coutances

September 7, 2023 Sun Pharmaceutical Industries Inc. 69,707 cartons units

FDA Drug Class III Terminated

Dofetilide Capsules 500 mcg (0.5mg), 60-count bottle, Rx Only, Manufactured by Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191, (U.T of D & NH), India, Distributed by: Sun Pha

July 18, 2023 Sun Pharmaceutical Industries Inc. 360 60-count bottles units

FDA Drug Class II Terminated

Methylphenidate Hydrochloride Tablets, USP 20mg, Rx Only, 100 Tablets per bottle, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries Inc., C

July 13, 2023 Sun Pharmaceutical Industries Inc. 7313 bottles units

FDA Drug Class II Terminated

Tiagabine Hydrochloride Tablets, 2 mg, 30-count bottle, Distributed by Sun Pharmaceutical Industries. Inc. Cranbury NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited Halol-Baroda Highwa

July 10, 2023 Sun Pharmaceutical Industries Inc. 8,880 30-count bottles units

FDA Drug Class III Terminated

Loteprednol Etabonate Ophthalmic Suspension, 5 mg/mL (0.5%), packaged as one bottle in a carton in a) 10 mL bottle (NDC# 62756-232-55) and b) 15 mL bottle (NDC # 62756-232-56), Rx only, Distributed by

July 5, 2023 Sun Pharmaceutical Industries Inc. 20,884 cartons units

FDA Drug Class II Terminated

Amphotericin B Liposome for Injection, 50mg/vial, Rx only, Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by Sun Pharmaceutical Medicare Limited, Baska Ujeti Road,

May 30, 2023 Sun Pharmaceutical Industries Inc. 12960 vials units

FDA Drug Class II Terminated

buPROPrion Hydrochloride Extended-Release Tablets, USP (SR) 150 mg, 60 Tablets, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ, Manufactured by: Sun Pharmaceutical Industri

May 9, 2023 Sun Pharmaceutical Industries Inc. 5,344 Bottles units

FDA Drug Class II Terminated

Buprenorphine Sublingual Tablets, 8 mg, 30 count-bottles, Rx only, Manufactured by: Sun Pharma, NDC 62756-460-83.

May 3, 2023 Sun Pharmaceutical Industries Inc. 12,336 bottles units

FDA Drug Class III Terminated

Norepinephrine Bitartrate Injection, USP, 4 mg/4 mL* (1 mg/mL), 4 mL Single-dose Fliptop Vial (NDC 47335-615-40); packaged in 10 x 4 mL Single-dose Fliptop Vials per carton (NDC 47335-615-44); Rx only

March 29, 2023 Sun Pharmaceutical Industries Inc. 16,450 vials units

FDA Drug Class III Terminated

Dofetilide Capsules, 500 mcg (0.5 mg), 60-count bottle, Rx only, Manufactured by: Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India, NDC 47335-0063-86

March 9, 2023 Sun Pharmaceutical Industries Inc. 1,920 bottles units

FDA Drug Class II Terminated

Diltiazem Hydrochloride Extended-Release Capsules, USP, 360 mg; Rx only; 90-count bottles, Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway, Halol-389350, Gujarat, India; Distr

January 13, 2023 Sun Pharmaceutical Industries Inc. Lot # HAC3120A: 6912 Bottles; Lot # HAC3121A: 6792 Bottles; Lot # HAC4460A: 6816 Bottles; Lot # HAD0365A: 6744 Bottles; Lot # HAD1452A: 6840 Bottles units