Details for New Drug Application (NDA): 075347
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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. Forty-eight suppliers are listed for this compound. Additional details are available on the omeprazole magnesium profile page.
Summary for 075347
Tradename: | OMEPRAZOLE |
Applicant: | Actavis Labs Fl Inc |
Ingredient: | omeprazole |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 075347
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, DELAYED REL PELLETS;ORAL | Strength | 10MG | ||||
Approval Date: | May 30, 2008 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, DELAYED REL PELLETS;ORAL | Strength | 20MG | ||||
Approval Date: | May 30, 2008 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, DELAYED REL PELLETS;ORAL | Strength | 40MG | ||||
Approval Date: | May 30, 2008 | TE: | AB | RLD: | No |
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