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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050444
Company: REMPEX

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MINOCIN MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE/VIAL INJECTABLE;INJECTION Prescription AP 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
03/31/2025 SUPPL-53 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/050444s053lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/050444Orig1s053ltr.pdf
10/23/2014 SUPPL-48 Labeling-Package Insert

Label is not available on this site.
09/14/2010 SUPPL-47 Labeling-Package Insert

Label is not available on this site.
01/16/2007 SUPPL-45 Labeling

Label is not available on this site.
09/28/2005 SUPPL-44 Labeling

Label is not available on this site.
05/27/2004 SUPPL-43 Labeling

Label is not available on this site.
05/27/2004 SUPPL-42 Labeling

Label is not available on this site.
02/17/2005 SUPPL-38 Labeling

Label is not available on this site.
05/31/2002 SUPPL-36 Labeling

Label is not available on this site.
01/30/2002 SUPPL-34 Labeling

Label is not available on this site.
01/30/2002 SUPPL-33 Labeling

Label is not available on this site.
03/29/1996 SUPPL-31 Labeling

Label is not available on this site.
01/30/2002 SUPPL-29 Labeling

Label is not available on this site.
04/12/1978 SUPPL-27 Labeling

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.
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.
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.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
03/31/2025 SUPPL-53 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/050444s053lbl.pdf

MINOCIN

INJECTABLE;INJECTION; EQ 100MG BASE/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MINOCIN MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE/VIAL INJECTABLE;INJECTION Prescription Yes AP 050444 REMPEX
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 214934 NEXUS
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