Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 063009
Company: ZYDUS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE CAPSULE;ORAL Prescription AB No Yes
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE;ORAL Prescription AB 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
03/02/1992 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/20/2020 SUPPL-43 Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.

04/20/2020 SUPPL-41 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

04/20/2020 SUPPL-40 Labeling-Package Insert

Label is not available on this site.

12/13/2010 SUPPL-38 Labeling-Package Insert

Label is not available on this site.

01/02/2013 SUPPL-34 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/063009s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/063009Orig1s034ltr.pdf
01/30/2008 SUPPL-31 Labeling

Label is not available on this site.

08/12/2003 SUPPL-25 Labeling

Label is not available on this site.

08/13/2003 SUPPL-24 Manufacturing (CMC)-New Strength

Label is not available on this site.

06/07/2001 SUPPL-23 Manufacturing (CMC)-Facility

Label is not available on this site.

12/07/2000 SUPPL-22 Manufacturing (CMC)-Facility

Label is not available on this site.

12/07/2000 SUPPL-21 Manufacturing (CMC)-Facility

Label is not available on this site.

12/07/2000 SUPPL-20 Manufacturing (CMC)-Facility

Label is not available on this site.

10/26/2000 SUPPL-19 Manufacturing (CMC)-Facility

Label is not available on this site.

07/07/2000 SUPPL-18 Manufacturing (CMC)-Facility

Label is not available on this site.

03/15/2000 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

03/15/2000 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

09/20/1999 SUPPL-15 Manufacturing (CMC)-Facility

Label is not available on this site.

09/20/1999 SUPPL-14 Manufacturing (CMC)-Facility

Label is not available on this site.

09/20/1999 SUPPL-13 Manufacturing (CMC)-Facility

Label is not available on this site.

09/20/1999 SUPPL-12 Manufacturing (CMC)-Facility

Label is not available on this site.

12/10/1997 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

06/18/1997 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

04/29/1996 SUPPL-9 Labeling

Label is not available on this site.

02/16/1995 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

09/06/1994 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

03/31/1994 SUPPL-6 Labeling

Label is not available on this site.

10/06/1993 SUPPL-5 Labeling

Label is not available on this site.

06/11/1993 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

06/11/1993 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

11/02/1993 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

04/17/1992 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/02/2013 SUPPL-34 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/063009s034lbl.pdf

MINOCYCLINE HYDROCHLORIDE

CAPSULE;ORAL; EQ 100MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DYNACIN MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE CAPSULE;ORAL Prescription No AB 063067 CNTY LINE PHARMS
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

CAPSULE;ORAL; EQ 75MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DYNACIN MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE;ORAL Prescription No AB 063067 CNTY LINE PHARMS
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE;ORAL Prescription No AB 065470 AUROBINDO PHARMA
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE;ORAL Prescription No AB 065005 IMPAX LABS
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE;ORAL Prescription No AB 090867 SUN PHARM INDS INC
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE;ORAL Prescription No AB 065062 TORRENT
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE;ORAL Prescription No AB 063065 WATSON LABS
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE;ORAL Prescription No AB 063009 ZYDUS

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