Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065485
Company: BARR LABS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 45MG BASE TABLET, EXTENDED RELEASE;ORAL Discontinued None No No
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 90MG BASE TABLET, EXTENDED RELEASE;ORAL Discontinued None No No
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 135MG BASE TABLET, EXTENDED RELEASE;ORAL Discontinued None No No
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 65MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 115MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 80MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 105MG BASE TABLET, EXTENDED RELEASE;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
03/17/2009 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
06/28/2019 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

04/26/2017 SUPPL-8 Manufacturing (CMC)-New Strength Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/065485Orig1s005,065485Orig1s008TAltr.pdf
11/26/2014 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

11/14/2011 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

04/26/2017 SUPPL-5 Manufacturing (CMC)-New Strength Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/065485Orig1s005,065485Orig1s008TAltr.pdf
05/18/2012 SUPPL-4 Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/065485Orig1s004ltr.pdf

MINOCYCLINE HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL; EQ 65MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 65MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204453 ALKEM LABS LTD
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 65MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202261 AUROBINDO PHARMA LTD
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 65MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 065485 BARR LABS INC
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 65MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 091118 SUN PHARM INDS LTD
SOLODYN MINOCYCLINE HYDROCHLORIDE EQ 65MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 050808 MEDICIS

TABLET, EXTENDED RELEASE;ORAL; EQ 115MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 115MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204453 ALKEM LABS LTD
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 115MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202261 AUROBINDO PHARMA LTD
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 115MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 065485 BARR LABS INC
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 115MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 091118 SUN PHARM INDS LTD
SOLODYN MINOCYCLINE HYDROCHLORIDE EQ 115MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 050808 MEDICIS

TABLET, EXTENDED RELEASE;ORAL; EQ 80MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 80MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204453 ALKEM LABS LTD
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 80MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202261 AUROBINDO PHARMA LTD
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 80MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 065485 BARR LABS INC
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 80MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 203443 MYLAN
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 80MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204394 SIDMAK LABS INDIA
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 80MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 091118 SUN PHARM INDS LTD
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 80MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 203553 ZYDUS PHARMS
SOLODYN MINOCYCLINE HYDROCHLORIDE EQ 80MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 050808 MEDICIS

TABLET, EXTENDED RELEASE;ORAL; EQ 105MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 105MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204453 ALKEM LABS LTD
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 105MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202261 AUROBINDO PHARMA LTD
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 105MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 065485 BARR LABS INC
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 105MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 203443 MYLAN
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 105MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204394 SIDMAK LABS INDIA
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 105MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 091118 SUN PHARM INDS LTD
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 105MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 203553 ZYDUS PHARMS
SOLODYN MINOCYCLINE HYDROCHLORIDE EQ 105MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 050808 MEDICIS

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