Application 207487
- Type
- ANDA
- Sponsor
- ABHAI LLC
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 |
|---|---|---|---|---|---|
| 10702-150 | Hydrocodone Bitartrate and Homatropine Methylbromide | hydrocodone bitartrate and homatropine methylbromide oral solution | KVK-Tech, Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 47399 | ORIG | 2017-03-02 |