Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075061
Company: FOSUN PHARMA
Company: FOSUN PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NAPROXEN | NAPROXEN | 375MG | TABLET, DELAYED RELEASE;ORAL | Discontinued | None | No | No |
| NAPROXEN | NAPROXEN | 500MG | TABLET, DELAYED 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 |
|---|---|---|---|---|---|---|---|
| 02/18/1998 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75061ap.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/20/2015 | SUPPL-27 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/29/2008 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 04/29/2008 | SUPPL-20 | Labeling |
Label is not available on this site. |
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| 11/28/2007 | SUPPL-19 | Labeling |
Label is not available on this site. |
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| 07/15/2007 | SUPPL-16 | Labeling |
Label is not available on this site. |
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| 12/10/2003 | SUPPL-12 | Labeling |
Label is not available on this site. |
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| 05/10/2002 | SUPPL-5 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 05/10/2002 | SUPPL-4 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 10/03/2001 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/03/2001 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 08/02/2000 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |