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Details for New Drug Application (NDA): 075576

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NDA 075576 describes OMEPRAZOLE, which is a drug marketed by Kremers Urban Pharms, Sandoz, Dexcel Pharma, Actavis Labs Fl Inc, Apotex, Zydus Pharms Usa Inc, Aurobindo Pharma Usa, Glenmark Generics, Dr Reddys Labs Ltd, Mylan, Lupin Ltd, Impax Labs, Gastroentero, Aurolife Pharma Llc, Ajanta Pharma Ltd, Actavis Elizabeth, Par Pharm, and Perrigo R And D, and is included in twenty-six NDAs. It is available from one hundred suppliers. There is one patent 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 thirteen drug master file entries for this compound. Nineteen suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the omeprazole magnesium profile page.

Summary for NDA: 075576

Dr Reddys Labs Ltd
Therapeutic Class:Gastrointestinal Agents

Pharmacology for NDA: 075576

Suppliers and Packaging for NDA: 075576

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CAPSULE, DELAYED REL PELLETS;ORAL 075576 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-2302 0615-2302-05 15 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (0615-2302-05)
CAPSULE, DELAYED REL PELLETS;ORAL 075576 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-2302 0615-2302-39 30 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (0615-2302-39)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrength40MG
Approval Date:Jan 21, 2009TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrength20MG
Approval Date:Oct 22, 2007TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrength10MG
Approval Date:Oct 22, 2007TE:ABRLD:No

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.