Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075482
Company: IVAX SUB TEVA PHARMS
Company: IVAX SUB TEVA PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ENALAPRIL MALEATE | ENALAPRIL MALEATE | 2.5MG | TABLET;ORAL | Discontinued | None | No | No |
ENALAPRIL MALEATE | ENALAPRIL MALEATE | 5MG | TABLET;ORAL | Discontinued | None | No | No |
ENALAPRIL MALEATE | ENALAPRIL MALEATE | 10MG | TABLET;ORAL | Discontinued | None | No | No |
ENALAPRIL MALEATE | ENALAPRIL MALEATE | 20MG | 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 |
---|---|---|---|---|---|---|---|
08/22/2000 | ORIG-1 | Approval |
Letter (PDF)
Letter (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75482ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75482ta.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/29/2002 | SUPPL-13 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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09/12/2001 | SUPPL-9 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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05/25/2001 | SUPPL-8 | Labeling |
Label is not available on this site. |
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05/25/2001 | SUPPL-7 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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02/21/2001 | SUPPL-6 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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10/22/2001 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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02/21/2001 | SUPPL-2 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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02/21/2001 | SUPPL-1 | Manufacturing (CMC)-Facility |
Label is not available on this site. |