Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 063065
Company: WATSON LABS
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 No
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
12/30/1991 ORIG-1 Approval Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/63065_Minocycline Hydrochloride.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/05/2020 SUPPL-59 Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.

05/05/2020 SUPPL-58 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

05/05/2020 SUPPL-56 Labeling-Package Insert

Label is not available on this site.

11/20/2008 SUPPL-44 Labeling

Label is not available on this site.

04/25/2008 SUPPL-40 Labeling

Label is not available on this site.

10/22/2001 SUPPL-20 Labeling

Label is not available on this site.

10/22/2001 SUPPL-19 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/25/2001 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

06/02/1999 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

06/10/1999 SUPPL-15 Labeling Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/63065S015_Minocycline%20Hydrochloride_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/63065s14s15apl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/063065s14s15_Minocycline_toc.cfm
06/10/1999 SUPPL-14 Manufacturing (CMC)-New Strength Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/63065S015_Minocycline%20Hydrochloride_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/63065s14s15apl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/063065s14s15_Minocycline_toc.cfm
12/09/1998 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

04/07/1998 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

04/07/1998 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

04/07/1998 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

05/12/1998 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

05/12/1998 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

11/05/1997 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

05/08/1996 SUPPL-5 Labeling

Label is not available on this site.

03/04/1996 SUPPL-3 Labeling

Label is not available on this site.

07/22/1992 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
06/10/1999 SUPPL-15 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/63065S015_Minocycline%20Hydrochloride_Prntlbl.pdf
06/10/1999 SUPPL-14 Manufacturing (CMC)-New Strength Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/63065S015_Minocycline%20Hydrochloride_Prntlbl.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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