Application 021591
- Type
- NDA
- Sponsor
- RANBAXY
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | RIOMET | METFORMIN HYDROCHLORIDE | SOLUTION;ORAL | 500MG/5ML | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 10631-206 | Riomet | Metformin Hydrochloride | Sun Pharmaceutical Industries, Inc. | NDA | Current |
| 10631-238 | Riomet | Metformin Hydrochloride | Sun Pharmaceutical Industries, Inc. | NDA | Current |
| 71800-008 | Metformin Hydrochloride | Metformin Hydrochloride | INNOVIDA PHARMACEUTIQUE CORPORATION | NDA | Current |
| 71800-008 | Metformin Hydrochloride | Metformin Hydrochloride | INNOVIDA PHARMACEUTIQUE CORPORATION | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 56454 | SUPPL | 2018-11-15 |
| 56383 | SUPPL | 2018-11-08 |
| 47952 | SUPPL | 2017-04-12 |
| 47926 | SUPPL | 2017-04-11 |
| 28212 | SUPPL | 2010-12-10 |
| 37307 | SUPPL | 2010-12-06 |
| 37306 | SUPPL | 2008-11-07 |
| 5815 | SUPPL | 2008-10-23 |
| 28211 | SUPPL | 2005-10-20 |
| 37305 | SUPPL | 2005-09-30 |
| 42225 | ORIG | 2005-01-11 |
| 15844 | SUPPL | 2004-06-07 |
| 5814 | SUPPL | 2004-06-07 |
| 37304 | ORIG | 2003-09-26 |
| 5813 | ORIG | 2003-09-25 |