Application 072344
- Type
- ANDA
- Sponsor
- ACP NIMBLE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ACEPHEN | ACETAMINOPHEN | SUPPOSITORY;RECTAL | 325MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0713-0164 | ACEPHEN | Acetaminophen | Cosette Pharmaceuticals, Inc. | ANDA | Current |
| 0713-0164 | ACEPHEN | Acetaminophen | G&W Laboratories, Inc. | ANDA | Current |
| 68788-8934 | ACEPHEN | Acetaminophen | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 76413-302 | ACEPHEN | Acetaminophen | Central Texas Community Health Centers | ANDA | Current |