Details for New Drug Application (NDA): 011790
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NDA 011790 describes ROBAXIN, which is a drug marketed by Hikma and Endo Operations and is included in two NDAs. It is available from one supplier. Additional details are available on the ROBAXIN profile page.
The generic ingredient in ROBAXIN is methocarbamol. There are twenty-seven drug master file entries for this compound. Sixty-two suppliers are listed for this compound. Additional details are available on the methocarbamol profile page.
The generic ingredient in ROBAXIN is methocarbamol. There are twenty-seven drug master file entries for this compound. Sixty-two suppliers are listed for this compound. Additional details are available on the methocarbamol profile page.
Summary for 011790
| Tradename: | ROBAXIN |
| Applicant: | Hikma |
| Ingredient: | methocarbamol |
| Patents: | 0 |
Pharmacology for NDA: 011790
| Physiological Effect | Centrally-mediated Muscle Relaxation |
Medical Subject Heading (MeSH) Categories for 011790
Suppliers and Packaging for NDA: 011790
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ROBAXIN | methocarbamol | SOLUTION;IM-IV | 011790 | NDA | Hikma Pharmaceuticals USA Inc. | 0641-6103 | 0641-6103-10 | 10 VIAL in 1 CARTON (0641-6103-10) / 10 mL in 1 VIAL (0641-6103-01) |
| ROBAXIN | methocarbamol | SOLUTION;IM-IV | 011790 | NDA | Hikma Pharmaceuticals USA Inc. | 0641-6103 | 0641-6103-25 | 25 VIAL in 1 CARTON (0641-6103-25) / 10 mL in 1 VIAL (0641-6103-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;IM-IV | Strength | 1GM/10ML (100MG/ML) | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AP | RLD: | Yes | ||||
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