Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019790
Company: ENDO OPERATIONS
Company: ENDO OPERATIONS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DILATRATE-SR | ISOSORBIDE DINITRATE | 40MG | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | 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 |
---|---|---|---|---|---|---|---|
09/02/1988 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/24/2014 | SUPPL-11 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019790s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019790Orig1s011ltr.pdf | |
01/30/2002 | SUPPL-9 | Labeling |
Label is not available on this site. |
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10/29/1999 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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01/13/1999 | SUPPL-7 | Labeling |
Label is not available on this site. |
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07/09/1998 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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05/31/1996 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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03/12/1996 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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03/13/1996 | SUPPL-3 | Labeling |
Label is not available on this site. |
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12/09/1991 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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08/20/1991 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
10/24/2014 | SUPPL-11 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019790s011lbl.pdf |