Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050444
Company: REMPEX PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MINOCIN MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE/VIAL INJECTABLE;INJECTION Prescription None Yes Yes
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; Orphan

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/17/2015 SUPPL-49 Manufacturing (CMC) 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/2015/050444s049lbl.pdf
10/23/2014 SUPPL-48 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050444s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050444Orig1s048ltr.pdf
09/14/2010 SUPPL-47 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050444s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050444s047ltr.pdf
01/16/2007 SUPPL-45 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-44 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-43 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50444slr042,043ltr.pdf
05/27/2004 SUPPL-42 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50444slr042,043ltr.pdf
02/17/2005 SUPPL-38 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/50444s038,50445s022,50649s015ltr.pdf
06/21/2001 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

05/31/2002 SUPPL-36 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
07/29/1997 SUPPL-35 Manufacturing (CMC)-Control

Label is not available on this site.

01/30/2002 SUPPL-34 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50444s34ltr.pdf
01/30/2002 SUPPL-33 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50444s34ltr.pdf
03/29/1996 SUPPL-31 Labeling

Label is not available on this site.

03/04/1996 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

01/30/2002 SUPPL-29 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50444s34ltr.pdf
06/27/1978 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

04/12/1978 SUPPL-27 Labeling

Label is not available on this site.

07/12/1978 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

06/08/1978 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

01/14/1977 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

08/11/1976 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

06/25/1976 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

12/24/1975 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

05/12/1975 SUPPL-17 Manufacturing (CMC)-Formulation

Label is not available on this site.

03/21/1975 SUPPL-16 Efficacy-New Dosing Regimen

Label is not available on this site.

11/04/1974 SUPPL-14 Labeling

Label is not available on this site.

10/04/1973 SUPPL-13 Labeling

Label is not available on this site.

08/31/1973 SUPPL-12 Manufacturing (CMC)-Formulation

Label is not available on this site.

06/28/1973 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

02/08/1973 SUPPL-10 Manufacturing (CMC)-Formulation

Label is not available on this site.

05/12/1992 SUPPL-9 Labeling

Label is not available on this site.

08/28/1991 SUPPL-8 Labeling

Label is not available on this site.

11/07/1988 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

10/06/1987 SUPPL-4 Labeling

Label is not available on this site.

01/10/1986 SUPPL-2 Labeling

Label is not available on this site.

07/25/1984 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
04/17/2015 SUPPL-49 Manufacturing (CMC) Label (PDF) Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050444s049lbl.pdf
10/23/2014 SUPPL-48 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050444s048lbl.pdf
09/14/2010 SUPPL-47 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050444s047lbl.pdf
01/16/2007 SUPPL-45 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050444s045,050445s027lbl.pdf
09/28/2005 SUPPL-44 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050444s044lbl.pdf

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