Jubilant Cadista Pharmaceuticals Inc.

FDA Drug Class III Terminated

Prochlorperazine Maleate Tablets, USP 5mg, 100 tablets, RX Only, Jubilant Cadista Pharmaceuticals, Inc., Salisbury, Maryland 21801, NDC 59746-113-06

December 27, 2022 Jubilant Cadista Pharmaceuticals Inc. 14,061 bottles units

FDA Drug Class II Terminated

Irbesartan Tablets, USP, 150mg, 90- count bottles, Rx only, Manufactured by: Jubilant Generics Ltd. Roorkee- 247661, India, Marketed by: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA,

July 18, 2022 Jubilant Cadista Pharmaceuticals Inc. 9,600 bottles units

FDA Drug Class II Terminated

Irbesartan Tablets, USP, 75 mg, 90- count bottle, Rx only, Manufactured by: Jubilant Generics Ltd. Roorkee- 247661, India, Marketed by: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA,

July 18, 2022 Jubilant Cadista Pharmaceuticals Inc. 28,560 bottles units

FDA Drug Class III Terminated

Methylprednisolone Tablets, USP 4mg, 100-count bottle, Rx Only, Manufactured by: Jubliant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-001-06

April 1, 2022 Jubilant Cadista Pharmaceuticals Inc. 19,222 Bottles (100-count) units

FDA Drug Class I Terminated

Meclizine Hydrochloride Tablets USP, 12.5 mg, packaged in a case of 24 bottles (100-count bottle), Rx only, Manufactured by: Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD, 21801, NDC 59746-122

March 8, 2022 Jubilant Cadista Pharmaceuticals Inc. 12,174 bottles units

FDA Drug Class III Terminated

Donepezil HCL Tablets, USP, 5 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd. India, Marketed by: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801 NDC 59746-329-90

August 20, 2021 Jubilant Cadista Pharmaceuticals Inc. 14,544 bottles units

FDA Drug Class II Terminated

Itraconazole Capsules, 100 mg, 30-count bottles, Rx only, Manufactured by: Jubilant Generics Ltd., Roorkee - 247661, India; Marketed by: Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD 21801, ND

April 1, 2021 Jubilant Cadista Pharmaceuticals Inc. Lot #IT119008B - (4,128 Bottles); Lot #IT20001A - (3,984 Bottles); Lot #IT20002B - (4.080 Bottles) units

FDA Drug Class III Terminated

Methylprednisolone Tablets USP, 4 MG, packaged in a 21-count blister pack, Rx only, Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD 21801, NDC 59746-001-03

February 19, 2021 Jubilant Cadista Pharmaceuticals Inc. 635,400 cartons units

FDA Drug Class II Terminated

clomiPRAMINE Hydrochloride Capsules USP, 50 mg, 30-count bottle, Rx Only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD NDC 59746-711-30

November 6, 2020 Jubilant Cadista Pharmaceuticals Inc. 4,416 bottles units

FDA Drug Class III Terminated

Olanzapine Orally Disintegrating Tablets, 5 mg, 30 count (3x10 unit dose) blister pack, Rx only, Manufactured by: Jubilant Generics, Ltd., Roorkee, India, Marketed by: Jubilant Cardista Pharmaceutical

October 26, 2020 Jubilant Cadista Pharmaceuticals Inc. 23,616 blister packs units

FDA Drug Class III Terminated

Lamotrigine Tablets, USP, 150 mg, 20,000-count bulk container, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, USA, For repackaging by: AvKare Inc., Pulaski, TN 38478, Bul

May 26, 2020 Jubilant Cadista Pharmaceuticals Inc. 1,313,333 tablets units

FDA Drug Class II Terminated

Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg, 90 count bottle, Rx Only, Manufactured by Jubilant Generics Ltd, Roorkee-247661 India, NDC 59746-284-90

March 11, 2020 Jubilant Cadista Pharmaceuticals Inc. 89,376 90-count bottles units

FDA Drug Class II Terminated

Amantadine Hydrochloride Tablets, 100 mg, 100-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd., Roorkee-247661, India; Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 2

December 2, 2019 Jubilant Cadista Pharmaceuticals Inc. 1,824 bottles units

FDA Drug Class II Terminated

Pantoprazole Sodium Delayed Release Tablets, USP, 40 mg, packaged in 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd, Roorkee - 247661, India, Marketed by: Jubilant Cadista Pharmaceut

September 4, 2019 Jubilant Cadista Pharmaceuticals Inc. 63,216 bottles units

FDA Drug Class I Terminated

Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.02 mg, packaged into a carton containing 3 blister cards each blister card contains 28-film coated, biconvex tablets, Rx Only, Manufactured by:

July 9, 2019 Jubilant Cadista Pharmaceuticals Inc. 11,412 cartons/34,236 blister cards/28 tablets each card units

FDA Drug Class II Terminated

Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg*, 90-count bottle, Rx Only, Manufactured by: Jubilant Generics Ltd., Roorkee - 247661, India; Marketed by: Jubilant Cadista Pharmaceuticals Inc.

March 29, 2019 Jubilant Cadista Pharmaceuticals Inc. 12,960 bottles units

FDA Drug Class III Terminated

BuPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150 mg, a) 30 count (NDC 59746- 758-30) & b) 90 count (NDC 59746-758-90) bottles, Rx only, Manufactured b Jubilant Generis Ltd, Roorkee, Indi

February 28, 2019 Jubilant Cadista Pharmaceuticals Inc. a) 3,072 bottles; b) 2,688 bottles units

FDA Drug Class II Terminated

Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg*, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd., Roorkee - 247661, India; Marketed by: Jubilant Cadista Pharmaceuticals Inc.

October 2, 2018 Jubilant Cadista Pharmaceuticals Inc. 158,466 bottles units

FDA Drug Class III Terminated

MethylPREDNISolone Tablets, USP, 4 mg, 21-count blister pack. Rx Only. Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD NDC 59746-001-03

August 27, 2018 Jubilant Cadista Pharmaceuticals Inc. 89,722 blister pack units

FDA Drug Class III Terminated

Valsartan Tablets USP, 80 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roorkee 0247661 India, Marketed by: Jubilant Cardista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC

August 14, 2018 Jubilant Cadista Pharmaceuticals Inc. 9,552 bottles units

FDA Drug Class III Terminated

Valsartan Tablets USP, 40 mg, 30-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roorkee 0247661 India, Marketed by: Jubilant Cardista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC

August 14, 2018 Jubilant Cadista Pharmaceuticals Inc. 10,577 bottles units

FDA Drug Class III Terminated

Valsartan Tablets USP, 320 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roorkee 0247661 India, Marketed by: Jubilant Cardista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC

August 14, 2018 Jubilant Cadista Pharmaceuticals Inc. 7,048 bottles units

FDA Drug Class III Terminated

Valsartan Tablets USP, 160 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roorkee 0247661 India, Marketed by: Jubilant Cardista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC

August 14, 2018 Jubilant Cadista Pharmaceuticals Inc. 18,947 bottles units

FDA Drug Class III Terminated

Valsartan Tablets USP, 320 mg, 90 tablet, Rx Only, Manufactured by: Jubilant Generics Ltd. Roorkee - 247661, India, Marketed by: Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD 21801, NDC 59746-

May 25, 2018 Jubilant Cadista Pharmaceuticals Inc. 2,328 bottles (Lot VR417065A) and 2,352 bottles (Lot VR417066A) units

FDA Drug Class III Terminated

Meclizine hydrochloride tablets USP, 12.5 mg, 100 count HDPE bottle, Rx only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, NDC 59746-122-06

October 30, 2017 Jubilant Cadista Pharmaceuticals Inc. 744 bottles units

FDA Drug Class III Terminated

Methylprednisolone Tablets, USP, 16 mg, 50-count bottles, Rx only, Manufactured by Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, NDC 59746-003-14.

June 13, 2016 Jubilant Cadista Pharmaceuticals Inc. 1512 bottles units

FDA Drug Class III Terminated

BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 200 mg, packaged in a) 60-count bottles (NDC 59746-317-60) and b) 100-count bottles (NDC 59746-317-01), Rx only, Manufactured by: Julibant L

April 8, 2016 Jubilant Cadista Pharmaceuticals Inc. 19,682 bottles units

FDA Drug Class III Terminated

BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 100 mg, packaged in a) 60-count bottles (NDC 59746-315-60) and b) 100-count bottles (NDC 59746-315-01), Rx only, Manufactured by: Julibant L

April 8, 2016 Jubilant Cadista Pharmaceuticals Inc. 20,882 bottles units

FDA Drug Class III Terminated

BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, packaged in a) 60-count bottles (NDC 59746-316-60) and b) 100-count bottles (NDC 59746-316-01), Rx only, Manufactured by: Julibant L

April 8, 2016 Jubilant Cadista Pharmaceuticals Inc. 81,077 bottles units

FDA Drug Class II Terminated

Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 90-tablets per bottle, Rx Only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, NDC # 59746-339-90

July 11, 2014 Jubilant Cadista Pharmaceuticals Inc. 9,358 bottles units

FDA Drug Class II Terminated

Pantoprazole Sodium Delayed Release Tablets USP, 40 mg, 90 count bottles, Manufactured by Jubilant Life Sciences Ltd, Roorkee-247661 India ;Marketed by Jubilant Cadista Pharmaceuatical Inc Salisbury,

February 11, 2013 Jubilant Cadista Pharmaceuticals Inc. 12770 bottles units