Application 203695
- Type
- ANDA
- Sponsor
- ACTAVIS LABS FL INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | METAXALONE | METAXALONE | TABLET;ORAL | 800MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0591-2341 | Metaxalone | Metaxalone | Actavis Pharma, Inc. | ANDA | Current |
| 0591-2341 | Metaxalone | Metaxalone | Actavis Pharma, Inc. | ANDA | Current |
| 45865-985 | Metaxalone | Metaxalone | medsource pharmaceuticals | ANDA | Current |
| 50090-3174 | Metaxalone | Metaxalone | A-S Medication Solutions | ANDA | Current |
| 50090-3174 | Metaxalone | Metaxalone | A-S Medication Solutions | ANDA | Current |
| 50090-3297 | Metaxalone | Metaxalone | A-S Medication Solutions | ANDA | Current |
| 50436-0449 | Metaxalone | Metaxalone | Unit Dose Services | ANDA | Current |
| 55700-911 | Metaxalone | Metaxalone | Quality Care Products, LLC | ANDA | Current |
| 55700-911 | Metaxalone | Metaxalone | Quality Care Products, LLC | ANDA | Current |
| 60760-093 | Metaxalone | Metaxalone | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 63629-8014 | Metaxalone | Metaxalone | Bryant Ranch Prepack | ANDA | Current |
| 63629-8014 | Metaxalone | Metaxalone | Bryant Ranch Prepack | ANDA | Current |
| 63629-8014 | Metaxalone | Metaxalone | Bryant Ranch Prepack | ANDA | Current |
| 63629-8014 | Metaxalone | Metaxalone | Bryant Ranch Prepack | ANDA | Current |
| 63629-8014 | Metaxalone | Metaxalone | Bryant Ranch Prepack | ANDA | Current |
| 68788-7018 | Metaxalone | Metaxalone | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7018 | Metaxalone | Metaxalone | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7018 | Metaxalone | Metaxalone | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7018 | Metaxalone | Metaxalone | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7018 | Metaxalone | Metaxalone | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 69306-100 | Metaxalone | Metaxalone | Doc Rx | ANDA | Current |
| 69306-100 | Metaxalone | Metaxalone | Doc Rx | ANDA | Current |
| 69306-100 | Metaxalone | Metaxalone | Doc Rx | ANDA | Current |
| 69306-100 | Metaxalone | Metaxalone | Doc Rx | ANDA | Current |
| 69306-100 | Metaxalone | Metaxalone | Doc Rx | ANDA | Current |
| 69306-100 | Metaxalone | Metaxalone | Doc Rx | ANDA | Current |
| 69306-100 | Metaxalone | Metaxalone | Doc Rx | ANDA | Current |
| 70518-0818 | Metaxalone | Metaxalone | REMEDYREPACK INC. | ANDA | Current |
| 70518-0818 | Metaxalone | Metaxalone | REMEDYREPACK INC. | ANDA | Current |
| 70518-0818 | Metaxalone | Metaxalone | REMEDYREPACK INC. | ANDA | Current |
| 70518-0818 | Metaxalone | Metaxalone | REMEDYREPACK INC. | ANDA | Current |
| 70518-0818 | Metaxalone | Metaxalone | REMEDYREPACK INC. | ANDA | Current |
| 70518-0818 | Metaxalone | Metaxalone | REMEDYREPACK INC. | ANDA | Current |
| 71205-326 | Metaxalone | Metaxalone | Proficient Rx LP | ANDA | Current |
| 71205-326 | Metaxalone | Metaxalone | Proficient Rx LP | ANDA | Current |
| 71205-326 | Metaxalone | Metaxalone | Proficient Rx LP | ANDA | Current |
| 71335-0375 | Metaxalone | Metaxalone | Bryant Ranch Prepack | ANDA | Current |
| 80425-0131 | Skelaxin | Metaxalone 800mg | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0131 | Metaxalone | Metaxalone | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0131 | Metaxalone | Metaxalone | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |