Application 201295
- Type
- ANDA
- Sponsor
- TRIS PHARMA INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | SOLUTION;ORAL | 325MG/15ML;7.5MG/15ML | No | No |
| 002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | SOLUTION;ORAL | 300MG/15ML;10MG/15ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 27808-049 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Tris Pharma Inc | ANDA | Current |
| 27808-130 | hydrocodone bitartrate and acetaminophen | hydrocodone bitartrate and acetaminophen | Tris Pharma Inc | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 76481 | ORIG | 2023-11-07 |