Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050451
Company: TRIAX PHARMS
Company: TRIAX PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 08/10/1982 | 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 |
|---|---|---|---|---|---|
| 08/08/1995 | SUPPL-25 | Labeling |
Label is not available on this site. |
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| 05/12/1992 | SUPPL-23 | Labeling |
Label is not available on this site. |
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| 03/30/1989 | SUPPL-21 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 10/06/1987 | SUPPL-15 | Labeling |
Label is not available on this site. |
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| 10/08/1986 | SUPPL-13 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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| 06/27/1986 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 10/29/1986 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 12/01/1986 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 01/29/1985 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 03/23/1984 | SUPPL-7 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 12/16/1983 | SUPPL-6 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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| 08/25/1983 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 05/05/1983 | SUPPL-3 | Labeling |
Label is not available on this site. |
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| 04/27/1983 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 04/27/1983 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |