Application 081051
- Type
- ANDA
- Sponsor
- MIKART
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | SOLUTION;ORAL | 500MG/15ML;7.5MG/15ML | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 43176 | SUPPL | 2005-07-22 |
| 43175 | SUPPL | 2005-07-22 |
| 43174 | SUPPL | 2005-07-22 |
| 43173 | SUPPL | 2005-07-22 |
| 43172 | SUPPL | 2005-07-22 |
| 43171 | SUPPL | 2005-07-22 |
| 43170 | SUPPL | 2005-07-22 |
| 43169 | SUPPL | 2005-07-22 |
| 43168 | SUPPL | 2005-07-22 |
| 43167 | SUPPL | 2005-07-22 |
| 22648 | SUPPL | 2005-07-22 |
| 22647 | SUPPL | 2005-07-22 |
| 22646 | SUPPL | 2005-07-22 |
| 22645 | SUPPL | 2005-07-22 |
| 22644 | SUPPL | 2005-07-22 |
| 22643 | SUPPL | 2005-07-22 |
| 22642 | SUPPL | 2005-07-22 |
| 22641 | SUPPL | 2005-07-22 |
| 22640 | SUPPL | 2005-07-22 |
| 43166 | ORIG | 2005-07-15 |