Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075390
Company: AUROBINDO PHARMA USA
Company: AUROBINDO PHARMA USA
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 |
---|---|---|---|---|---|---|---|
04/19/2001 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-390_Naproxen_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75390ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-390_Naproxen.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/19/2020 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
03/19/2020 | SUPPL-6 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
03/19/2020 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
09/23/2008 | SUPPL-3 | Labeling |
Label is not available on this site. |
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09/25/2007 | SUPPL-2 | Labeling |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
04/19/2001 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-390_Naproxen_prntlbl.pdf |