Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074782
Company: CONTRACT PHARMACAL
Company: CONTRACT PHARMACAL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| IBUPROFEN | IBUPROFEN | 200MG | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 07/06/1998 | ORIG-1 | Approval |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74782ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/74782apTOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/22/2006 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 10/27/2000 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/01/1999 | SUPPL-2 | Labeling |
Label is not available on this site. |