Application 214955
- Type
- ANDA
- Sponsor
- AACE PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BUTALBITAL AND ACETAMINOPHEN | ACETAMINOPHEN; BUTALBITAL | TABLET;ORAL | 50MG;300MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 71406-109 | BUTALBITAL AND ACETAMINOPHEN | butalbital and acetaminophen | AACE Pharmaceuticals, Inc. | ANDA | Current |
| 71406-109 | BUTALBITAL AND ACETAMINOPHEN | butalbital and acetaminophen | AACE Pharmaceuticals, Inc. | ANDA | Current |
| 71406-109 | BUTALBITAL AND ACETAMINOPHEN | butalbital and acetaminophen | AACE Pharmaceuticals, Inc. | ANDA | Current |