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Details for New Drug Application (NDA): 200536

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NDA 200536 describes RANITIDINE HYDROCHLORIDE, which is a drug marketed by Ranbaxy, Wockhardt, Apotex Inc, Bio Pharm Inc, Pharm Assoc, Dr Reddys Labs Inc, Amneal Pharms, Strides Pharma, Watson Labs, Sandoz, Aurobindo Pharm, Mylan, Actavis Mid Atlantic, Amneal Pharms Ny, Watson Labs Inc, Perrigo R And D, Sun Pharm Inds Ltd, Zydus Pharms Usa Inc, Svads Holdings Sa, Dr Reddys Labs Ltd, Glenmark Generics, Tolmar, Teva, Eurohlth Intl Sarl, Boehringer Ingelheim, Bedford, Ivax Sub Teva Pharms, Torpharm, Mylan Labs Ltd, Taro, West-ward Pharms Int, Hi Tech Pharma, Apotex, Par Pharm, Breckenridge Pharm, Silarx, Vintage Pharms, Nostrum Labs Inc, Contract Pharmacal, and Perrigo, and is included in sixty-one NDAs. It is available from one hundred and thirty-one suppliers. Additional details are available on the RANITIDINE HYDROCHLORIDE profile page.

The generic ingredient in RANITIDINE HYDROCHLORIDE is ranitidine hydrochloride. There are forty-two drug master file entries for this compound. One hundred and thirty-eight suppliers are listed for this compound. Additional details are available on the ranitidine hydrochloride profile page.

Summary for NDA: 200536

Svads Holdings Sa
ranitidine hydrochloride
Therapeutic Class:Gastrointestinal Agents

Suppliers and Packaging for NDA: 200536

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ranitidine hydrochloride
TABLET;ORAL 200536 ANDA Walgreen Company 0363-0362 0363-0362-02 1 BOTTLE in 1 CARTON (0363-0362-02) > 200 TABLET in 1 BOTTLE
ranitidine hydrochloride
TABLET;ORAL 200536 ANDA Walgreen Company 0363-0362 0363-0362-23 1 BOTTLE in 1 CARTON (0363-0362-23) > 24 TABLET in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrengthEQ 150MG BASE
Approval Date:Jun 28, 2011TE:RLD:No

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