Application 091633
- Type
- ANDA
- Sponsor
- SUN PHARM INDS INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | HYDROCODONE BITARTRATE AND IBUPROFEN | HYDROCODONE BITARTRATE; IBUPROFEN | TABLET;ORAL | 2.5MG;200MG | No | No |
| 002 | HYDROCODONE BITARTRATE AND IBUPROFEN | HYDROCODONE BITARTRATE; IBUPROFEN | TABLET;ORAL | 5MG;200MG | No | No |
| 003 | HYDROCODONE BITARTRATE AND IBUPROFEN | HYDROCODONE BITARTRATE; IBUPROFEN | TABLET;ORAL | 7.5MG;200MG | No | No |
| 004 | HYDROCODONE BITARTRATE AND IBUPROFEN | HYDROCODONE BITARTRATE; IBUPROFEN | TABLET;ORAL | 10MG;200MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 57664-102 | Hydrocodone bitartrate and ibuprofen | Hydrocodone bitartrate and ibuprofen | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-203 | Hydrocodone bitartrate and ibuprofen | Hydrocodone bitartrate and ibuprofen | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-280 | Hydrocodone bitartrate and ibuprofen | Hydrocodone bitartrate and ibuprofen | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-281 | Hydrocodone bitartrate and ibuprofen | Hydrocodone bitartrate and ibuprofen | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 76094 | ORIG | 2023-11-02 |