InvaGen Pharmaceuticals, Inc.

FDA Drug Class I Completed

Vigabatrin for Oral Solution, USP 500 mg per packet, 50 packets per box, Rx Only, Manufactured by: InvaGen Pharmaceuticals, Inc., (a subsidiary of Cipla Ltd.), Hauppauge, NY, 11788, Manufactured for:

November 17, 2023 InvaGen Pharmaceuticals, Inc. 1240 boxes units

FDA Drug Class III Terminated

Gabapentin Tablets USP, 600 mg, Rx Only, 500-count bottle, Manufactured for: Exelan Pharmaceuticals, Inc., Lawrenceville, GA 30046, Manufactured by: InvaGen Pharmaceuticals, Inc., Hauppauge, NY 11788,

May 14, 2020 InvaGen Pharmaceuticals, Inc. 2,202 bottles units

FDA Drug Class III Terminated

Testosterone Topical Solution 30mg of testosterone per pump actuation * each actuation delivers 1.5 mL of solution Total contents: 110 mL to deliver 90 mL, Manufactured by: Cipla Ltd, Verna Goa, India

June 12, 2019 InvaGen Pharmaceuticals, Inc. 1776 bottles units

FDA Drug Class II Terminated

Testosterone Cypionate Injection, USP, 1000 mg/10 mL (100 mg/mL), For intramuscular use only, 10 mL Vial, Multiple-Dose, Rx Only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla

March 22, 2019 InvaGen Pharmaceuticals, Inc. 75968 vials units

FDA Drug Class II Terminated

Testosterone Cypionate Injection, USP, 2000 mg/10 mL (200 mg/mL), For intramuscular use only, 10 mL Vial, Multiple-Dose, Rx Only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla

March 22, 2019 InvaGen Pharmaceuticals, Inc. 12234 vials units

FDA Drug Class II Terminated

Testosterone Cypionate Injection, USP, 200 mg/mL, For IM use only, 1 mL Vial, Single Dose, Rx Only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla USA, Inc., 1560 Sawgrass Corp

March 22, 2019 InvaGen Pharmaceuticals, Inc. 692538 vials units

FDA Drug Class III Terminated

Amlodipine Besylate USP 10 mg Tablets, 1000-count bottles, Rx Only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla USA, Inc. 1560 Sawgrass Corporate Parkway, Suite 130, Sunrise

October 3, 2018 InvaGen Pharmaceuticals, Inc. 2880 bottles units

FDA Drug Class III Terminated

Bupropion Hydrochloride ER Tablets, USP 150 mg, packaged in a) 90-count bottle (NDC 69097-875-05), Manufactured for: Cipla USA Inc., 1560 Sawgrass Corporate Parkway, Suite 130 Sunrise, FL 33323 b) 90-

September 6, 2018 InvaGen Pharmaceuticals, Inc. 26,496 bottles units

FDA Drug Class III Terminated

buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 60 count bottles, Rx Only, Manufactured for: Cipla USA Inc. 1560 Sawgrass Corporate Parkway Suite 130 Sunrise, FL 33323, Manufactured by: In

March 15, 2018 InvaGen Pharmaceuticals, Inc. N/A units

FDA Drug Class III Terminated

buPROPion HCl Extended-Release Tablets, USP (SR), 150 mg ,a) 60 count (NDC 69097-878-03) and b) 100 count (NDC 69097-878-07) bottles, Rx Only, Manufactured for: Cipla USA Inc. 1560 Sawgrass Corpora

March 15, 2018 InvaGen Pharmaceuticals, Inc. N/A units

FDA Drug Class III Terminated

Decitabine for Injection, 50mg per vial, Rx only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla USA, Inc., 1560 Sawgrass Corporate Parkway, Suite 130, Sunrise, FL 33323, NDC 6

March 5, 2018 InvaGen Pharmaceuticals, Inc. 3222 vials units