Drugs@FDA: FDA-Approved Drugs
Company: ZYDUS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 100MG BASE | CAPSULE;ORAL | Prescription | AB | No | Yes |
| MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE;ORAL | Prescription | AB | 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 |
|---|---|---|---|---|---|---|---|
| 03/02/1992 | 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 |
|---|---|---|---|---|---|
| 04/20/2020 | SUPPL-43 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 04/20/2020 | SUPPL-41 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 04/20/2020 | SUPPL-40 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/13/2010 | SUPPL-38 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/02/2013 | SUPPL-34 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/063009s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/063009Orig1s034ltr.pdf | |
| 01/30/2008 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 08/12/2003 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 08/13/2003 | SUPPL-24 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |
||
| 06/07/2001 | SUPPL-23 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 12/07/2000 | SUPPL-22 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 12/07/2000 | SUPPL-21 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 12/07/2000 | SUPPL-20 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 10/26/2000 | SUPPL-19 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 07/07/2000 | SUPPL-18 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 03/15/2000 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/15/2000 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/20/1999 | SUPPL-15 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 09/20/1999 | SUPPL-14 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 09/20/1999 | SUPPL-13 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 09/20/1999 | SUPPL-12 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 12/10/1997 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/18/1997 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/29/1996 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 02/16/1995 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/06/1994 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/31/1994 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 10/06/1993 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 06/11/1993 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/11/1993 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/02/1993 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/17/1992 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 01/02/2013 | SUPPL-34 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/063009s034lbl.pdf |
MINOCYCLINE HYDROCHLORIDE
CAPSULE;ORAL; EQ 100MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| MINOCIN | MINOCYCLINE HYDROCHLORIDE | EQ 100MG BASE | CAPSULE;ORAL | Prescription | Yes | AB | 050649 | BAUSCH |
| MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 100MG BASE | CAPSULE;ORAL | Prescription | No | AB | 065470 | AUROBINDO PHARMA |
| MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 100MG BASE | CAPSULE;ORAL | Prescription | No | AB | 065005 | IMPAX LABS |
| MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 100MG BASE | CAPSULE;ORAL | Prescription | No | AB | 090867 | SUN PHARM INDS INC |
| MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 100MG BASE | CAPSULE;ORAL | Prescription | No | AB | 065062 | TORRENT |
| MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 100MG BASE | CAPSULE;ORAL | Prescription | No | AB | 063065 | WATSON LABS |
| MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 100MG BASE | CAPSULE;ORAL | Prescription | No | AB | 063009 | ZYDUS |
CAPSULE;ORAL; EQ 75MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE;ORAL | Prescription | No | AB | 065470 | AUROBINDO PHARMA |
| MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE;ORAL | Prescription | No | AB | 065005 | IMPAX LABS |
| MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE;ORAL | Prescription | No | AB | 090867 | SUN PHARM INDS INC |
| MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE;ORAL | Prescription | No | AB | 065062 | TORRENT |
| MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE;ORAL | Prescription | No | AB | 063065 | WATSON LABS |
| MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE;ORAL | Prescription | No | AB | 063009 | ZYDUS |