Application 011792
- Type
- NDA
- Sponsor
- MYLAN SPECIALITY LP
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | SOMA | CARISOPRODOL | TABLET;ORAL | 350MG | Yes | No |
| 003 | SOMA | CARISOPRODOL | CAPSULE;ORAL | 250MG | Yes | No |
| 004 | SOMA | CARISOPRODOL | TABLET;ORAL | 250MG | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0037-2001 | Soma | Carisoprodol | Meda Pharmaceuticals | NDA | Current |
| 0037-2001 | Soma | Carisoprodol | Meda Pharmaceuticals | NDA | Current |
| 0037-2001 | Soma | Carisoprodol | Meda Pharmaceuticals | NDA | Current |
| 0037-2001 | Soma | Carisoprodol | Meda Pharmaceuticals | NDA | Current |
| 0037-2250 | Soma | Carisoprodol | Meda Pharmaceuticals | NDA | Current |
| 0037-2250 | Soma | Carisoprodol | Meda Pharmaceuticals | NDA | Current |
| 0037-2250 | Soma | Carisoprodol | Meda Pharmaceuticals | NDA | Current |
| 0037-2250 | Soma | Carisoprodol | Meda Pharmaceuticals | NDA | Current |
| 21695-606 | Soma | Carisoprodol | Rebel Distributors Corp | NDA | Current |
| 51525-5901 | Carisoprodol | carisoprodol | Wallace Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC | Current |
| 51525-5901 | Carisoprodol | carisoprodol | Wallace Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC | Current |
| 51525-5901 | Carisoprodol | carisoprodol | Wallace Pharmaceuticals I | NDA AUTHORIZED | Current |
| 51525-5901 | Carisoprodol | carisoprodol | Wallace Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 58232 | SUPPL | 2019-04-05 |
| 58223 | SUPPL | 2019-04-05 |
| 55272 | SUPPL | 2018-08-23 |
| 11962 | SUPPL | 2015-02-25 |
| 33058 | SUPPL | 2013-02-06 |
| 287 | SUPPL | 2013-02-04 |
| 20030 | SUPPL | 2012-11-16 |
| 11961 | SUPPL | 2010-01-06 |
| 33057 | SUPPL | 2009-11-17 |
| 11960 | SUPPL | 2007-09-25 |
| 33056 | SUPPL | 2007-09-19 |
| 10780 | SUPPL | 2006-06-12 |
| 286 | SUPPL | 2006-06-12 |