Application 040201
- Type
- ANDA
- Sponsor
- MALLINCKRODT
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | TABLET;ORAL | 500MG;7.5MG | No | No |
| 002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | TABLET;ORAL | 500MG;10MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 42254-228 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Rebel Distributors Corp | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 22095 | ORIG | 1998-02-27 |