Application 207386
- Type
- ANDA
- Sponsor
- MIKART
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 |
|---|---|---|---|---|---|
| 46672-856 | butalbital and acetaminophen | butalbital and acetaminophen | Mikart, Inc. | ANDA | Current |
| 46672-856 | butalbital and acetaminophen | butalbital and acetaminophen | Mikart, LLC | ANDA | Current |
| 51862-538 | butalbital and acetaminophen | butalbital and acetaminophen | Mayne Pharma | ANDA | Current |
| 51862-538 | butalbital and acetaminophen | butalbital and acetaminophen | Mayne Pharma | ANDA | Current |
| 51862-538 | butalbital and acetaminophen | butalbital and acetaminophen | Mayne Pharma | ANDA | Current |