Application 207176
- Type
- ANDA
- Sponsor
- AVANTHI INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE | HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE | TABLET;ORAL | 1.5MG;5MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 10702-055 | Hydrocodone Bitartrate and Homatropine Methylbromide | Hydrocodone Bitartrate and Homatropine Methylbromide | KVK-Tech, Inc. | ANDA | Current |