Application 207635
- Type
- ANDA
- Sponsor
- CNTY LINE PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BUTALBITAL AND ACETAMINOPHEN | ACETAMINOPHEN; BUTALBITAL | TABLET;ORAL | 300MG;50MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 47781-534 | butalbital and acetaminophen | butalbital and acetaminophen | Alvogen Inc. | ANDA | Current |
| 47781-534 | butalbital and acetaminophen | butalbital and acetaminophen | Alvogen Inc. | ANDA | Current |
| 47781-534 | butalbital and acetaminophen | butalbital and acetaminophen | Alvogen Inc. | ANDA | Current |
| 47781-644 | butalbital and acetaminophen | butalbital and acetaminophen | Alvogen Inc. | ANDA | Current |
| 47781-644 | butalbital and acetaminophen | butalbital and acetaminophen | Alvogen Inc. | ANDA | Current |