Application 203535
- Type
- ANDA
- Sponsor
- NOVEL LABS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE | HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE | SYRUP;ORAL | 1.5MG/5ML;5MG/5ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 40032-810 | Hydrocodone Bitartrate and Homatropine Methylbromide | Hydrocodone Bitartrate and Homatropine Methylbromide | Novel Laboratories, Inc. | ANDA | Current |