Details for New Drug Application (NDA): 213201
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NDA 213201 describes OMEPRAZOLE MAGNESIUM, which is a drug marketed by Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, L Perrigo Co, Spil, Aurobindo Pharma, Hetero Labs Ltd Iii, P And L, and Perrigo R And D, and is included in eight NDAs. It is available from forty-eight suppliers. Additional details are available on the OMEPRAZOLE MAGNESIUM profile page.
The generic ingredient in OMEPRAZOLE MAGNESIUM 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.
The generic ingredient in OMEPRAZOLE MAGNESIUM 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.
Summary for 213201
| Tradename: | OMEPRAZOLE MAGNESIUM |
| Applicant: | Aurobindo Pharma Ltd |
| Ingredient: | omeprazole magnesium |
| Patents: | 0 |
Pharmacology for NDA: 213201
| Mechanism of Action | Cytochrome P450 2C19 Inhibitors Proton Pump Inhibitors |
Suppliers and Packaging for NDA: 213201
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OMEPRAZOLE MAGNESIUM | omeprazole magnesium | CAPSULE, DELAYED RELEASE;ORAL | 213201 | ANDA | Aurohealth LLC | 58602-837 | 58602-837-05 | 1 BOTTLE in 1 CARTON (58602-837-05) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE, DELAYED RELEASE;ORAL | Strength | EQ 20MG BASE | ||||
| Approval Date: | Apr 28, 2023 | TE: | RLD: | No | |||||
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