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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050649
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MINOCIN MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE;ORAL Discontinued None Yes No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
07/19/2017 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
07/19/2017 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
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