Details for New Drug Application (NDA): 075785

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NDA 075785 describes OMEPRAZOLE, which is a drug marketed by Actavis Labs Fl Inc, Apotex, Aurobindo Pharma, Breckenridge, Dr Reddys Labs Ltd, Glenmark Pharms Ltd, Hetero Labs Ltd Iii, Impax Labs, Lannett Co Inc, Lupin Ltd, Norvium Bioscience, Sandoz, Strides Pharma, Teva Pharms Usa, Xiromed, Zydus Pharms Usa Inc, Dexcel Pharma, Dr Reddys, Sun Pharm, Dexcel, Ajanta Pharma Ltd, Anda Repository, Aurolife Pharma Llc, Chartwell Rx, Perrigo R And D, Sciegen Pharms Inc, Zydus, Zydus Pharms, Aurobindo Pharma Ltd, L Perrigo Co, Spil, and P And L, and is included in forty-six NDAs. It is available from ninety-nine suppliers. There are three patents protecting this drug and one Paragraph IV challenge. Additional details are available on the OMEPRAZOLE profile page.

The generic ingredient in OMEPRAZOLE is omeprazole magnesium. There are one hundred and thirty-one drug master file entries for this compound. Fifty suppliers are listed for this compound. Additional details are available on the omeprazole magnesium profile page.

Anti-Ulcer Agents
Proton Pump Inhibitors

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, DELAYED REL PELLETS;ORAL			Strength	10MG
Approval Date:	Oct 22, 2007	TE:	AB	RLD:	No

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, DELAYED REL PELLETS;ORAL			Strength	20MG
Approval Date:	Oct 22, 2007	TE:	AB	RLD:	No

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, DELAYED REL PELLETS;ORAL			Strength	40MG
Approval Date:	Jan 21, 2009	TE:	AB	RLD:	No

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