Drugs@FDA: FDA-Approved Drugs
Company: EPIC PHARMA LLC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ISONIAZID | ISONIAZID | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
ISONIAZID | ISONIAZID | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|---|---|
11/17/1952 | 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 |
---|---|---|---|---|---|
07/13/2016 | SUPPL-28 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/008678s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/008678Orig1s028ltr.pdf |
04/23/2007 | SUPPL-26 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/008678s025,s026ini.pdf |
04/23/2007 | SUPPL-25 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/008678s025,s026ini.pdf |
07/13/2000 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
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02/07/2000 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
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03/06/1997 | SUPPL-21 | Labeling |
Label is not available on this site. |
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11/21/1995 | SUPPL-20 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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08/01/1996 | SUPPL-19 | Labeling |
Label is not available on this site. |
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08/10/1992 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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08/10/1992 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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09/23/1988 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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05/09/1985 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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09/10/1987 | SUPPL-14 | Labeling |
Label is not available on this site. |
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01/04/1984 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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08/19/1983 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
08/19/1983 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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03/28/1983 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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03/28/1983 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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09/30/1980 | SUPPL-7 | 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 |
---|---|---|---|---|---|
07/13/2016 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/008678s028lbl.pdf |