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Wednesday, July 4, 2018

NEWS 04 JULY 2018

USFDA NEWS

COMPANY

DRUG

NEWS

Elite Pharmaceuticals

Oxycodone Hydrochloride and Acetaminophen

Elite Pharmaceuticals Receives FDA Approval For Generic Percocet Tablets

Unichem Laboratories

Montelukast Chewable tablet

Unichem laboratories receive ANDA approval for Montelukast chewable tablets 4mg and 5mg

 

·         USFDA publishes final guidance on — Amendments to ANDA Under GDUFA

                            

Other ANDA Approvals

COMPANY

DRUG

Corresponding RLD

Cipla

Emtricitabine

Emtriva (Gilead)

Groupe parima inc

Desoximetasone cream

Topicort (Taro)

Indicus pharma

Propafenone hydrochloride

Rythmol SR (GSK)

Accord hlthcare

Azacitidine

Vidaza (Celgene)

MSN labs pvt ltd

Capecitabine

Xeloda (Roche)

Watson labs teva

Nicotine polacrilex

Nicorette (GSK)

Mylan labs ltd

Docetaxel

Docetaxel (Hospira)

Apc pharms llc

Dicyclomine hydrochloride

Bentyl (Allergan)

 

*For browsing official press releases click on the respective news item.

 

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