Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 063067
Company: ALVOGEN
Company: ALVOGEN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DYNACIN | MINOCYCLINE HYDROCHLORIDE | EQ 100MG BASE | CAPSULE;ORAL | Discontinued | None | No | No |
| DYNACIN | MINOCYCLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE;ORAL | Discontinued | None | No | No |
| DYNACIN | MINOCYCLINE HYDROCHLORIDE | EQ 50MG BASE | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 07/31/1990 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/23/2014 | SUPPL-38 | Labeling-Package Insert |
Label is not available on this site. |
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| 08/04/2003 | SUPPL-24 | Labeling |
Label is not available on this site. |
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| 09/15/1999 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/15/1999 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/15/1999 | SUPPL-15 | Labeling |
Label is not available on this site. |
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| 09/15/1999 | SUPPL-14 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |
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| 12/02/1999 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 12/02/1999 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/24/1999 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/14/1997 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 04/24/1996 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 06/24/1996 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/24/1996 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/24/1996 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/07/1994 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 12/21/1993 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/13/1993 | SUPPL-3 | Labeling |
Label is not available on this site. |
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| 03/16/1992 | SUPPL-2 | Labeling |
Label is not available on this site. |
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| 09/30/1991 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |