Par Pharmaceutical Inc.

FDA Drug Class II Terminated

BusPIRone Hydrochloride Tablets, USP 7.5 mg NDC# 49884-725-01

August 10, 2020 Par Pharmaceutical Inc. 11,347 bottles units

FDA Drug Class II Terminated

Glycopyrrolate Tablets, USP 1 mg, 100-count bottle, Rx only, Dist. by: Par Pharmaceutical, Chestnut Ridge, NY, 10977, U.S.A, Mfg. by: Par Formulations Private Limited, 1/58, Pudupakkam, Kelambakkam -

March 30, 2020 Par Pharmaceutical Inc. 29,352 bottles units

FDA Drug Class III Terminated

PrediniSONE Tablets, USP 5 mg, 48-count bottle, Rx only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977, NDC 0603-5337-31

March 4, 2020 Par Pharmaceutical Inc. 13008 bottles units

FDA Drug Class III Terminated

Frovatriptan Succinate Tablets, 2.5mg, packaged in 1 blister card of 9 tablets per carton, Rx Only, Manufactured by: Almac Pharma Services Limited, Craigavon, BT63 5UA, UK; Manufactured for: Par Pharm

February 10, 2020 Par Pharmaceutical Inc. 9,936 cartons units

FDA Drug Class I Terminated

Mycophenolate Mofetil for Injection, USP 500 mg, 4 Single Dose Vials, Rx Only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC 342023-172-044

April 30, 2019 Par Pharmaceutical Inc. 4506 packs units

FDA Drug Class III Terminated

Pramipexole dihydrochloride extended release tablets, 0.75 mg, packaged in 30-count bottles, Rx only, Manufactured by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 10370-252-11

September 6, 2018 Par Pharmaceutical Inc. 16,207 (bottles of 30 tablets) units

FDA Drug Class II Terminated

Travoprost Ophthalmic Solution USP, 0.004%, a) 2.5 mL and b) 5 mL bottles, Rx only, FOR USE IN THE EYES ONLY, Made in India, Distributed by: Par Pharmaceutical Cos., Inc, Spring Valley, NY 10977

October 5, 2016 Par Pharmaceutical Inc. a) 182,856 bottles; b) 59,448 bottles units

FDA Drug Class III Completed

Gildess FE 1.5/30 (norethindrone acetate, 1.5 mg and ethinyl estradiol tablets, 0.03 mg, USP and ferrous fumarate tablets, USP 75 mg), 6 blisters (28 count), NDC 0603-7608-17, Rx only, Manufactured in

September 27, 2016 Par Pharmaceutical Inc. 278,406 tablets units

FDA Drug Class III Completed

Gildess FE 1/20 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0.02 mg, USP and ferrous fumarate tablets, USP 75 mg), 28 count, 6 blisters (NDC 0603-7609-17), Rx only, Manufactured in Can

September 27, 2016 Par Pharmaceutical Inc. 822,009 tablets units

FDA Drug Class III Completed

Gildess 24 FE 1.5/30 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0.02 mg, USP and ferrous fumarate tablets, USP 75 mg), 28 count, (a) 3 blisters (NDC 0603-7610-49), and (b) 6 blisters

September 27, 2016 Par Pharmaceutical Inc. 44,127 tablets units

FDA Drug Class III Completed

Gildess 1.5/30 (norethindrone acetate, 1.5 mg and ethinyl estradiol tablets, 0.03 mg, USP), 21 count, (a) 3 blisters (NDC 0603-7606-48) and (b) 6 blisters (NDC 0603-7606-15), Rx only, Manufactured in

September 27, 2016 Par Pharmaceutical Inc. 221,017 tablets units

FDA Drug Class III Completed

Gildess 1/20 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0,02 mg, USP), 21 count, (a) 3 blisters (NDC 0603-7607-48) and (b) 6 blisters (NDC 0603-7607-15), Rx only, Manufactured in Cana

September 27, 2016 Par Pharmaceutical Inc. 393,981 tablets units

FDA Drug Class III Terminated

Meclizine Hydrochloride Tablets USP, 25 mg Tablets, Packaged in a) 100 Ct Bottles (NDC: 49884-035-01) and b) 1000 Ct Bottles (NDC: 49884-035-10), Rx only. Par Pharmaceutical Companies, Inc., Spring Va

October 26, 2015 Par Pharmaceutical Inc. a) 387,100 Bottles; b) 63,572 Bottles units

FDA Drug Class III Terminated

Meclizine Hydrochloride Tablets, USP, 12.5 mg Tablets, Packaged in a) 100 Ct Bottles (NDC: 49884-034-01) and b) 1000 Ct Bottles (NDC: 49884-034-10), Rx only. Par Pharmaceutical Companies, Inc., Spring

October 26, 2015 Par Pharmaceutical Inc. a) 162,385 Bottles; b) 6949 Bottles units

FDA Drug Class II Terminated

Mafenide Acetate, USP, For 5% Topical Solution, STERILE, Net Wt. 50 grams sterile powder per packet, Rx only, PAR Pharmaceuticals label --- Distributed by: Par Pharmaceutical Companies, Inc. Spring Va

February 12, 2015 Par Pharmaceutical Inc. 2856 cartons (each containing 5 packets) units

FDA Drug Class II Terminated

HydrALAZINE Hydrochloride Tablets, USP 25 mg, 100 count bottle Rx only, Distributed by: Par Pharmaceutical Companies, Inc. Spring Valley, NY10977

November 24, 2014 Par Pharmaceutical Inc. 38,788 bottles units