Details for New Drug Application (NDA): 206582
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The generic ingredient in OMEPRAZOLE MAGNESIUM is omeprazole magnesium. There are one hundred and thirty-one drug master file entries for this compound. Fifty-one suppliers are listed for this compound. Additional details are available on the omeprazole magnesium profile page.
Summary for 206582
Tradename: | OMEPRAZOLE MAGNESIUM |
Applicant: | P And L |
Ingredient: | omeprazole magnesium |
Patents: | 0 |
Pharmacology for NDA: 206582
Mechanism of Action | Cytochrome P450 2C19 Inhibitors Proton Pump Inhibitors |
Suppliers and Packaging for NDA: 206582
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OMEPRAZOLE MAGNESIUM | omeprazole magnesium | TABLET, DELAYED RELEASE;ORAL | 206582 | ANDA | P & L Development, LLC | 59726-297 | 59726-297-14 | 1 BOTTLE in 1 CARTON (59726-297-14) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE |
OMEPRAZOLE MAGNESIUM | omeprazole magnesium | TABLET, DELAYED RELEASE;ORAL | 206582 | ANDA | P & L Development, LLC | 59726-297 | 59726-297-28 | 2 BOTTLE in 1 CARTON (59726-297-28) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | EQ 20MG BASE | ||||
Approval Date: | Jun 1, 2020 | TE: | RLD: | No |
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