Application 213115
- Type
- ANDA
- Sponsor
- GRANULES PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BUTALBITAL AND ACETAMINOPHEN | ACETAMINOPHEN; BUTALBITAL | CAPSULE;ORAL | 300MG;50MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 70010-054 | butalbital and acetaminophen | butalbital and acetaminophen | Granules Pharmaceuticals Inc. | ANDA | Current |
| 70010-054 | butalbital and acetaminophen | butalbital and acetaminophen | Granules Pharmaceuticals Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 63105 | ORIG | 2020-05-19 |