Drugs@FDA: FDA-Approved Drugs
Company: REMPEX
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MINOCIN | MINOCYCLINE HYDROCHLORIDE | EQ 100MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 10/26/1972 | ORIG-1 | Approval | UNKNOWN; Orphan |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/23/2014 | SUPPL-48 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/14/2010 | SUPPL-47 | Labeling-Package Insert |
Label is not available on this site. |
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| 01/16/2007 | SUPPL-45 | Labeling |
Label is not available on this site. |
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| 09/28/2005 | SUPPL-44 | Labeling |
Label is not available on this site. |
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| 05/27/2004 | SUPPL-43 | Labeling |
Label is not available on this site. |
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| 05/27/2004 | SUPPL-42 | Labeling |
Label is not available on this site. |
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| 02/17/2005 | SUPPL-38 | Labeling |
Label is not available on this site. |
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| 05/31/2002 | SUPPL-36 | Labeling |
Label is not available on this site. |
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| 01/30/2002 | SUPPL-34 | Labeling |
Label is not available on this site. |
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| 01/30/2002 | SUPPL-33 | Labeling |
Label is not available on this site. |
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| 03/29/1996 | SUPPL-31 | Labeling |
Label is not available on this site. |
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| 01/30/2002 | SUPPL-29 | Labeling |
Label is not available on this site. |
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| 04/12/1978 | SUPPL-27 | Labeling |
Label is not available on this site. |
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| 03/21/1975 | SUPPL-16 | Efficacy-New Dosing Regimen |
Label is not available on this site. |
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| 11/04/1974 | SUPPL-14 | Labeling |
Label is not available on this site. |
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| 10/04/1973 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 05/12/1992 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 08/28/1991 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 10/06/1987 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 01/10/1986 | SUPPL-2 | Labeling |
Label is not available on this site. |
MINOCIN
INJECTABLE;INJECTION; EQ 100MG BASE/VIAL
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| MINOCIN | MINOCYCLINE HYDROCHLORIDE | EQ 100MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | Yes | AP | 050444 | REMPEX |
| MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 100MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 214934 | NEXUS PHARMS |