Application 073314
- Type
- ANDA
- Sponsor
- ACP NIMBLE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | INDOMETHACIN | INDOMETHACIN | SUPPOSITORY;RECTAL | 50MG | No | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0713-0176 | INDOMETHACIN | INDOMETHACIN | G & W LABORATORIES, INC. | ANDA | Current |
| 0713-0176 | INDOMETHACIN | INDOMETHACIN | Cosette Pharmaceuticals, Inc. | ANDA | Current |
| 42211-102 | INDOCIN | Indomethacin | Iroko Pharmaceuticals, LLC | ANDA | Current |
| 69344-102 | INDOCIN | Indomethacin | Zyla Life Sciences US Inc. | ANDA | Current |
| 69344-102 | INDOCIN | Indomethacin | Egalet US Inc. | ANDA | Current |
| 69344-102 | INDOCIN | Indomethacin | Zyla Life Sciences US Inc. | ANDA | Current |
| 69344-102 | INDOCIN | Indomethacin | Zyla Life Sciences US Inc. | ANDA | Current |