Amneal Pharmaceuticals, Inc.

FDA Drug Class II Ongoing

Ranitidine Tablets, USP 150 mg, 1000-count bottles, NDC 53746-253-10.

November 22, 2019 Amneal Pharmaceuticals, Inc. N/A units

FDA Drug Class II Ongoing

Ranitidine Tablets, USP 300 mg - a).30-count bottles (NDC 65162-254-30), b).100-count bottles (NDC 65162-254-10) and c). 250-count bottles (NDC 65162-254-25).

November 22, 2019 Amneal Pharmaceuticals, Inc. N/A units

FDA Drug Class II Ongoing

Ranitidine Tablets, USP 300 mg, 250-count bottles, NDC 53746-254-02.

November 22, 2019 Amneal Pharmaceuticals, Inc. N/A units

FDA Drug Class II Ongoing

Ranitidine Tablets, USP 150 mg a).60-count bottles (NDC 65162-253-06) , b).100-count bottles (NDC 65162-253-10), c).180-count bottles (NDC 65162-253-18), d).500-count bottles (NDC 65162-253-50) and e

November 22, 2019 Amneal Pharmaceuticals, Inc. N/A units

FDA Drug Class II Ongoing

Ranitidine Syrup Oral Solution 15 mg/mL 6. fl. oz. (473 mL), NDC 65162-664-90.

November 22, 2019 Amneal Pharmaceuticals, Inc. N/A units

FDA Drug Class III Terminated

Isotretinoin Capsules, USP 10 mg. Rx Only, 3 Prescription Blister Packs of 10- Capsules Each (30 Capsules)-. Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC 69238-1174-3

October 16, 2019 Amneal Pharmaceuticals, Inc. 2460 cartons/3 blister cards/10 capsules each units

FDA Drug Class III Terminated

Benazepril HCl Tablets, USP 40 mg, 100 count bottles, Rx only, Distributed by Amneal Pharmaceuticals, Bridgewater, NJ NDC 65162-754-10

September 24, 2019 Amneal Pharmaceuticals, Inc. 9,720 100 count bottles units

FDA Drug Class III Terminated

Methylergonovine Maleate USP 0.2 mg Tablets a) 12 count (NDC 69238-1605-02) and b) 28 count bottles (NDC 69238-1605-08)

July 18, 2019 Amneal Pharmaceuticals, Inc. a) 2,256 bottles; b) 240 bottles units

FDA Drug Class III Terminated

Esterified Estrogens & Methyltestosterone Tablets, USP 0.625 mg/1.25 mg, 100-count bottles, Rx Only, Manufactured by: Ammeal Pharmaceuticals of NY Hauppauge, NY 11788 Distributed by: Seton Pharmaceut

September 25, 2017 Amneal Pharmaceuticals, Inc. 19104 units units

FDA Drug Class III Terminated

Esterified Estrogens & Methyltestosterone Tablets, USP 1.25 mg/2.5 mg, 100-count bottles, Rx Only, Manufactured by: Ammeal Pharmaceuticals of NY Hauppauge, NY 11788 Distributed by: Seton Pharmaceutic

September 25, 2017 Amneal Pharmaceuticals, Inc. 19176 units units