Details for New Drug Application (NDA): 209312
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NDA 209312 describes METHOCARBAMOL, which is a drug marketed by Dr Reddys, Marsam Pharms Llc, Am Regent, Baxter Hlthcare Corp, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Monterey Pharms Llc, Navinta Llc, Norvium Bioscience, Sagent Pharms Inc, Slate Run Pharma, Somerset Theraps Llc, Able, Allied, Am Therap, Ani Pharms, Ascot, Aurobindo Pharma Ltd, Beximco Pharms Usa, Chartwell Molecular, Clonmel Hlthcare, Fosun Pharma, Granules, Hangzhou Binjiang, Heather, Hetero Labs Ltd Iii, Hikma Intl Pharms, Hlthcare, Impax Labs, Inwood Labs, Ivax Sub Teva Pharms, Kv Pharm, Mikart, Mylan, Nylos, Oxford Pharms, Pioneer Pharms, Prinston Inc, Puracap Pharm, Purepac Pharm, Roxane, Sandoz, Solvay, Sun Pharm Industries, Superpharm, Tablicaps, Upsher Smith, Watson Labs, Mcneil, Par Pharm, and Stevens J, and is included in seventy-four NDAs. It is available from sixty-one suppliers. Additional details are available on the METHOCARBAMOL profile page.
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.
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 209312
| Tradename: | METHOCARBAMOL |
| Applicant: | Granules |
| Ingredient: | methocarbamol |
| Patents: | 0 |
Pharmacology for NDA: 209312
| Physiological Effect | Centrally-mediated Muscle Relaxation |
Medical Subject Heading (MeSH) Categories for 209312
Suppliers and Packaging for NDA: 209312
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| METHOCARBAMOL | methocarbamol | TABLET;ORAL | 209312 | ANDA | Burel Pharmaceuticals, Inc. | 35573-413 | 35573-413-02 | 100 TABLET, COATED in 1 BOTTLE (35573-413-02) |
| METHOCARBAMOL | methocarbamol | TABLET;ORAL | 209312 | ANDA | Burel Pharmaceuticals, Inc. | 35573-413 | 35573-413-04 | 500 TABLET, COATED in 1 BOTTLE (35573-413-04) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
| Approval Date: | May 7, 2018 | TE: | AA | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 750MG | ||||
| Approval Date: | May 7, 2018 | TE: | AA | RLD: | No | ||||
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