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Friday, December 7, 2018

NEWS 07 DEC 2018

NEWS FROM USA

ANDA Approvals 

 

Approval Date

Drug Product

ANDA

Sponsor

Corresponding RLD

Number Of Other Approved Generics

05 Dec 2018

Candesartan Cilexetil Tablets

Alembic

Atacand (Ani Pharma)

Three

03 Dec 2018

Amlodipine Besylate; Olmesartan Medoxomil Tablets

Sciegen Pharms 

Azor (Daiichi)

Twelve

03 Dec 2018

Fluoxetine Hydrochloride Tablets

Teva Pharma

Fluoxetine Hydrochloride (Alvogen)

Three

04 Dec 2018

Brompheniramine Maleate; Dextromethorphan Hydrobromide; Pseudoephedrine Hydrochloride Syrup

Mayne Pharma

N/A

Five

04 Dec 2018

Toremifene Citrate Tablets

Eirgen Pharma 

Fareston (Kyowa)

None

04 Dec 2018

Prednisone Tablets

Geneyork 

N/A

Six

 

                            

USFDA INSPECTION

US FDA completes inspection of Lupin’s Mandideep location

 

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