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Details for New Drug Application (NDA): 022032
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The generic ingredient in OMEPRAZOLE is omeprazole magnesium. There are one hundred and thirty-one drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the omeprazole magnesium profile page.
Summary for 022032
Tradename: | OMEPRAZOLE |
Applicant: | Dexcel Pharma |
Ingredient: | omeprazole |
Patents: | 1 |
Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 022032
Suppliers and Packaging for NDA: 022032
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OMEPRAZOLE | omeprazole | TABLET, DELAYED RELEASE;ORAL | 022032 | NDA | L. Perrigo Company | 0113-0915 | 0113-0915-03 | 3 BOTTLE in 1 CARTON (0113-0915-03) > 14 TABLET, DELAYED RELEASE in 1 BOTTLE |
OMEPRAZOLE | omeprazole | TABLET, DELAYED RELEASE;ORAL | 022032 | NDA | L. Perrigo Company | 0113-0915 | 0113-0915-30 | 2 CARTON in 1 CARTON (0113-0915-30) > 14 BLISTER PACK in 1 CARTON > 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK |
Paragraph IV (Patent) Challenges for 022032
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
OMEPRAZOLE | TABLET, DELAYED RELEASE;ORAL | omeprazole | 022032 |
Profile for product number 001
Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | 20MG | ||||
Approval Date: | Dec 4, 2007 | TE: | RLD: | Yes | |||||
Patent: | Start Trial | Patent Expiration: | Aug 16, 2025 | Product Flag? | Y | Substance Flag? | Delist Request? |
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