Drugs@FDA: FDA-Approved Drugs
Company: BAUSCH
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MINOCIN | MINOCYCLINE HYDROCHLORIDE | EQ 50MG BASE | CAPSULE;ORAL | Prescription | AB | Yes | No |
MINOCIN | MINOCYCLINE HYDROCHLORIDE | EQ 100MG BASE | CAPSULE;ORAL | Prescription | AB | Yes | No |
MINOCIN | MINOCYCLINE HYDROCHLORIDE | EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|---|---|
05/31/1990 | ORIG-1 | Approval | Type 3 - New Dosage Form | 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 |
---|---|---|---|---|---|
07/18/2024 | SUPPL-28 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/050649s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/050649Orig1s028ltr.pdf | |
07/19/2017 | SUPPL-27 | 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/2017/050649s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050649Orig1s027ltr.pdf |
12/14/2016 | SUPPL-26 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050649s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050649Orig1s026ltr.pdf | |
03/09/2015 | SUPPL-25 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050649s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050649Orig1s025ltr.pdf | |
05/29/2014 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/14/2010 | SUPPL-23 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050649023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050649s023ltr.pdf | |
06/30/2008 | SUPPL-22 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050649s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050649s022ltr.pdf | |
05/30/2007 | SUPPL-21 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050649s021ltr.pdf |
01/23/2007 | SUPPL-20 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050649S020_LBL.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050649S020_LTR.pdf | |
04/02/2007 | SUPPL-19 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050649s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050649s019ltr.pdf | |
09/28/2005 | SUPPL-18 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050444s044,050445s026,050649s018ltr.pdf |
05/27/2004 | SUPPL-17 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50649slr016,017ltr.pdf |
05/27/2004 | SUPPL-16 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50649slr016,017ltr.pdf |
02/17/2005 | SUPPL-15 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/50444s038,50445s022,50649s015ltr.pdf |
01/28/2002 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
02/12/2001 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
03/29/2001 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/31/2002 | SUPPL-11 | Labeling |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50444s036ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/50-444S036_Minocin.cfm |
08/05/1998 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
08/05/1998 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/05/1998 | SUPPL-8 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
02/01/2002 | SUPPL-7 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50649s7ltr.pdf |
08/08/1995 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
02/01/2002 | SUPPL-5 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50649s7ltr.pdf |
01/28/1993 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
05/12/1992 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
03/26/1992 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
10/09/1991 | SUPPL-1 | 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 |
---|---|---|---|---|---|
07/18/2024 | SUPPL-28 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/050649s028lbl.pdf | |
07/18/2024 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/050649s028lbl.pdf | |
07/19/2017 | SUPPL-27 | 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/2017/050649s027lbl.pdf |
12/14/2016 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050649s026lbl.pdf | |
03/09/2015 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050649s025lbl.pdf | |
09/14/2010 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050649023lbl.pdf | |
06/30/2008 | SUPPL-22 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050649s022lbl.pdf | |
04/02/2007 | SUPPL-19 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050649s019lbl.pdf | |
01/23/2007 | SUPPL-20 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050649S020_LBL.pdf |
MINOCIN
CAPSULE;ORAL; EQ 50MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MINOCIN | MINOCYCLINE HYDROCHLORIDE | EQ 50MG BASE | CAPSULE;ORAL | Prescription | Yes | AB | 050649 | BAUSCH |
MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 50MG BASE | CAPSULE;ORAL | Prescription | No | AB | 065470 | AUROBINDO PHARMA |
MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 50MG BASE | CAPSULE;ORAL | Prescription | No | AB | 065005 | IMPAX LABS |
MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 50MG BASE | CAPSULE;ORAL | Prescription | No | AB | 090867 | SUN PHARM INDS INC |
MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 50MG BASE | CAPSULE;ORAL | Prescription | No | AB | 065062 | TORRENT |
MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 50MG BASE | CAPSULE;ORAL | Prescription | No | AB | 063181 | WATSON LABS TEVA |
MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 50MG BASE | CAPSULE;ORAL | Prescription | No | AB | 063011 | ZYDUS |
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 |