Application 075679
- Type
- ANDA
- Sponsor
- MYLAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | KETOPROFEN | KETOPROFEN | CAPSULE, EXTENDED RELEASE;ORAL | 200MG | No | Yes |
| 002 | KETOPROFEN | KETOPROFEN | CAPSULE, EXTENDED RELEASE;ORAL | 150MG | No | No |
| 003 | KETOPROFEN | KETOPROFEN | CAPSULE, EXTENDED RELEASE;ORAL | 100MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0378-8200 | Ketoprofen | ketoprofen | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-8200 | Ketoprofen | ketoprofen | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-8200 | Ketoprofen | ketoprofen | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-8200 | Ketoprofen | ketoprofen | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-8200 | Ketoprofen | ketoprofen | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-8200 | Ketoprofen | ketoprofen | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-8200 | Ketoprofen | ketoprofen | Mylan Pharmaceuticals Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 8762 | ORIG | 2003-04-10 |