Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050445
Company: BAUSCH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MINOCIN MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE/5ML SUSPENSION;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
10/26/1972 ORIG-1 Approval UNKNOWN

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/16/2018 SUPPL-30 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050445s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050445Orig1030ltr.pdf
02/25/2015 SUPPL-29 Labeling-Patient 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/2015/050445s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050445Orig1s029ltr.pdf
09/14/2010 SUPPL-28 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050445s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050445s028ltr.pdf
01/16/2007 SUPPL-27 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050444s045,050445s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050444s045, 050445s027ltr.pdf
09/28/2005 SUPPL-26 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050444s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050444s044,050445s026,050649s018ltr.pdf
05/27/2004 SUPPL-24 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50445slr023,024ltr.pdf
05/27/2004 SUPPL-23 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50445slr023,024ltr.pdf
02/17/2005 SUPPL-22 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-21 Manufacturing (CMC)-Control

Label is not available on this site.

03/26/2001 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

05/31/2002 SUPPL-19 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
08/12/1998 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

02/01/2002 SUPPL-17 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50445s11s13s17ltr.pdf
08/08/1995 SUPPL-16 Labeling

Label is not available on this site.

02/01/2002 SUPPL-15 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50445s11s13s17ltr.pdf
05/12/1992 SUPPL-14 Labeling

Label is not available on this site.

02/01/2002 SUPPL-13 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50445s11s13s17ltr.pdf
04/10/1991 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

02/01/2002 SUPPL-11 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50445s11s13s17ltr.pdf
10/06/1987 SUPPL-8 Labeling

Label is not available on this site.

05/01/1987 SUPPL-7 Labeling

Label is not available on this site.

10/29/1986 SUPPL-5 Labeling

Label is not available on this site.

01/16/1985 SUPPL-4 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

03/01/1983 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
11/16/2018 SUPPL-30 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050445s030lbl.pdf
02/25/2015 SUPPL-29 Labeling-Patient 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/2015/050445s029lbl.pdf
09/14/2010 SUPPL-28 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050445s028lbl.pdf
01/16/2007 SUPPL-27 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050444s045,050445s027lbl.pdf
09/28/2005 SUPPL-26 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050444s044lbl.pdf

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