Application 018858
- Type
- NDA
- Sponsor
- MYLAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | INDOMETHACIN | INDOMETHACIN | CAPSULE;ORAL | 25MG | No | No |
| 002 | INDOMETHACIN | INDOMETHACIN | CAPSULE;ORAL | 50MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0378-0143 | Indomethacin | indomethacin | Mylan Pharmaceuticals Inc. | NDA | Current |
| 0440-1652 | Indomethacin | indomethacin | Liberty Pharmaceuticals, Inc. | NDA | Current |
| 10544-234 | Indomethacin | indomethacin | Blenheim Pharmacal, Inc. | NDA | Current |
| 33261-133 | Indomethacin | indomethacin | Aidarex Pharmaceuticals LLC | NDA | Current |
| 51079-190 | Indomethacin | indomethacin | Mylan Institutional Inc. | NDA | Current |
| 55289-147 | Indomethacin | indomethacin | PD-Rx Pharmaceuticals, Inc. | NDA | Current |
| 67046-330 | Indomethacin | Indomethacin | Contract Pharmacy Services-PA | NDA | Current |