Cipla USA, Inc.

FDA Drug Class II Ongoing

Lanreotide Injection, 120 mg/0.5 mL, 0.5 mL per pre-filled syringe, For deep subcutaneous injection, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059.

January 2, 2026 Cipla USA, Inc. 15,221 syringes units

FDA Drug Class III Ongoing

Diclofenac Sodium Topical Gel, 1%, NET WT 100 g (3.53 oz), Manufactured by: DPT Laboratories, Ltd., 307 E Josephine Street, San Antonio, TX 78215. NDC: 76282-103-39

December 22, 2025 Cipla USA, Inc. 92,376 tubes units

FDA Drug Class II Ongoing

Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-410-02

November 14, 2025 Cipla USA, Inc. 63,504 bottles units

FDA Drug Class II Ongoing

Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-411-02

November 14, 2025 Cipla USA, Inc. 15,744 bottles units

FDA Drug Class II Ongoing

Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-412-02

November 14, 2025 Cipla USA, Inc. 12,576 bottles units

FDA Drug Class II Ongoing

Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack carton, Rx Only, Manufactured by: Invagen Pharmaceuticals, Inc., (a subsidary of Cipla Ltd) Hauppauge, NY 11786, Manufactur

October 24, 2025 Cipla USA, Inc. N/A units

FDA Drug Class II Ongoing

Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack carton, Rx Only, Manufactured by: Invagen Pharmaceuticals, Inc., Hauppauge, NY 11786, Manufactured for : Cipla USA, Inc., 1

October 24, 2025 Cipla USA, Inc. 1180 boxes units

FDA Drug Class III Ongoing

Albuterol Sulfate, Inhalation Aerosol, 90 mcg, 200 metered Inhalations, NET CONTENT 6.7 g, Manufactured by: Cipla Ltd, Indore, SEZ, Pithampur, India; Manufactured for: Cipla USA, Inc. 10 Independence

July 24, 2025 Cipla USA, Inc. 20352 packs (1x 200 MD) units

FDA Drug Class II Ongoing

Budesonide Inhalation Suspension, 0.5mg/2ml, 30 single-dose ampules per carton, five per pouch, RX Only, Manufactured by: Cipla Ltd. Indore SEZ, Pithampur, India. Manufactured for: Ciple USA, Inc. 10

June 30, 2025 Cipla USA, Inc. 13,680 ampoules units

FDA Drug Class II Ongoing

Lanthanum Carbonate Chewable Tablets, 1000mg, 10-count bottle, Rx only, Manufactured for Exelan Pharmaceuticals, NDC 76282-0478-90

October 23, 2024 Cipla USA, Inc. N/A units

FDA Drug Class II Ongoing

Lanthanum Carbonate Chewable Tablets, 1000mg, 10-count bottle, Rx only, Manufactured for Cipla USA, NDC 69097-0936-98

October 23, 2024 Cipla USA, Inc. 1,875 boxes (cipla and exlan) units

FDA Drug Class II Terminated

Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP, 0.5 mg & 3mg/3mL unit-dose vials, packaged in carton containing 30 vials ( 6 pouches of 5 - 3 mL vials), Rx only, Manufactured by: Ci

March 26, 2024 Cipla USA, Inc. 59244/3ml FFS packs units

FDA Drug Class I Terminated

Albuterol Sulfate Inhalation Aerosol, 90 mcg, 200 Metered Inhalation, net content 6.7 g canister packaged in a box, Rx only, Manufactured by: Cipla Ltd, Indore SE Z, Pithampur, India, Manufactured for

June 27, 2023 Cipla USA, Inc. 278,538 canisters units