Details for New Drug Application (NDA): 085123
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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 085123
Tradename: | METHOCARBAMOL |
Applicant: | Hikma Intl Pharms |
Ingredient: | methocarbamol |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 085123
Physiological Effect | Centrally-mediated Muscle Relaxation |
Medical Subject Heading (MeSH) Categories for 085123
Suppliers and Packaging for NDA: 085123
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
METHOCARBAMOL | methocarbamol | TABLET;ORAL | 085123 | ANDA | Bryant Ranch Prepack | 71335-0771 | 71335-0771-0 | 14 TABLET in 1 BOTTLE (71335-0771-0) |
METHOCARBAMOL | methocarbamol | TABLET;ORAL | 085123 | ANDA | Bryant Ranch Prepack | 71335-0771 | 71335-0771-1 | 20 TABLET in 1 BOTTLE (71335-0771-1) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 750MG | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No |
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