Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075679
Company: MYLAN
Company: MYLAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| KETOPROFEN | KETOPROFEN | 200MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | None | No | Yes |
| KETOPROFEN | KETOPROFEN | 150MG | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| KETOPROFEN | KETOPROFEN | 100MG | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 02/20/2002 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75679.ap.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/28/2021 | SUPPL-12 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 05/09/2016 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/08/2008 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 07/03/2006 | SUPPL-2 | Labeling |
Label is not available on this site. |