Application 089673
- Type
- ANDA
- Sponsor
- RHODES PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | TABLET;ORAL | 300MG;60MG | No | No |
| 002 | ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | TABLET;ORAL | 300MG;15MG | No | No |
| 003 | ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | TABLET;ORAL | 300MG;30MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 53489-161 | ACETAMINOPHEN AND CODEINE | Acetaminophen and Codeine Phosphate | Mutual Pharmaceutical Company, Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 76438 | ORIG | 2023-11-07 |