Details for New Drug Application (NDA): 090122
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The generic ingredient in MEPROBAMATE is aspirin; meprobamate. There are twenty-two drug master file entries for this compound. Additional details are available on the aspirin; meprobamate profile page.
Summary for 090122
Tradename: | MEPROBAMATE |
Applicant: | Alembic Pharms Ltd |
Ingredient: | meprobamate |
Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 090122
Suppliers and Packaging for NDA: 090122
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MEPROBAMATE | meprobamate | TABLET;ORAL | 090122 | ANDA | Alembic Pharmaceuticals Limited | 46708-019 | 46708-019-30 | 30 TABLET in 1 BOTTLE (46708-019-30) |
MEPROBAMATE | meprobamate | TABLET;ORAL | 090122 | ANDA | Alembic Pharmaceuticals Limited | 46708-019 | 46708-019-71 | 100 TABLET in 1 BOTTLE (46708-019-71) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
Approval Date: | Feb 18, 2009 | TE: | AA | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 400MG | ||||
Approval Date: | Feb 18, 2009 | TE: | AA | RLD: | No |
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