Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076608
Company: ANI PHARMS
Company: ANI PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE | FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE | 10MG;12.5MG | TABLET;ORAL | Discontinued | None | No | No |
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE | FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE | 20MG;12.5MG | TABLET;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 |
---|---|---|---|---|---|---|---|
12/03/2004 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76608ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/20/2020 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
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07/23/2020 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |