Details for New Drug Application (NDA): 212623
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The generic ingredient in METHOCARBAMOL is aspirin; methocarbamol. There are twenty-two drug master file entries for this compound. Additional details are available on the aspirin; methocarbamol profile page.
Summary for 212623
Tradename: | METHOCARBAMOL |
Applicant: | Allied |
Ingredient: | methocarbamol |
Patents: | 0 |
Pharmacology for NDA: 212623
Physiological Effect | Centrally-mediated Muscle Relaxation |
Medical Subject Heading (MeSH) Categories for 212623
Suppliers and Packaging for NDA: 212623
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
METHOCARBAMOL | methocarbamol | TABLET;ORAL | 212623 | ANDA | Marlex Pharmaceuticals, Inc. | 10135-722 | 10135-722-01 | 100 TABLET, FILM COATED in 1 BOTTLE (10135-722-01) |
METHOCARBAMOL | methocarbamol | TABLET;ORAL | 212623 | ANDA | Marlex Pharmaceuticals, Inc. | 10135-722 | 10135-722-05 | 500 TABLET, FILM COATED in 1 BOTTLE (10135-722-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
Approval Date: | Apr 30, 2021 | TE: | AA | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 750MG | ||||
Approval Date: | Apr 30, 2021 | TE: | AA | RLD: | No |
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