Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065156
Company: TORRENT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE TABLET;ORAL Prescription AB No No
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE TABLET;ORAL Prescription AB No No
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE TABLET;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
01/06/2004 ORIG-1 Approval Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/065156_s000_MinocyclineTOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/06/2020 SUPPL-17 Labeling-Package Insert

Label is not available on this site.

04/06/2020 SUPPL-15 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

05/11/2012 SUPPL-10 Labeling-Package Insert, Labeling-Container/Carton Labels Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/065156Orig1s010.pdf
10/27/2008 SUPPL-8 Labeling

Label is not available on this site.

06/23/2004 SUPPL-3 Labeling

Label is not available on this site.

MINOCYCLINE HYDROCHLORIDE

TABLET;ORAL; EQ 50MG 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 50MG BASE TABLET;ORAL Prescription No AB 213662 AUROBINDO PHARMA LTD
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE TABLET;ORAL Prescription No AB 065436 DR REDDYS LABS LTD
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE TABLET;ORAL Prescription No AB 065131 PAR PHARM
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE TABLET;ORAL Prescription No AB 090217 SUN PHARM INDUSTRIES
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE TABLET;ORAL Prescription No AB 065156 TORRENT

TABLET;ORAL; EQ 75MG 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 75MG BASE TABLET;ORAL Prescription No AB 213662 AUROBINDO PHARMA LTD
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE TABLET;ORAL Prescription No AB 065436 DR REDDYS LABS LTD
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE TABLET;ORAL Prescription No AB 065131 PAR PHARM
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE TABLET;ORAL Prescription No AB 090217 SUN PHARM INDUSTRIES
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE TABLET;ORAL Prescription No AB 065156 TORRENT

TABLET;ORAL; EQ 100MG 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 100MG BASE TABLET;ORAL Prescription No AB 213662 AUROBINDO PHARMA LTD
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE TABLET;ORAL Prescription No AB 065436 DR REDDYS LABS LTD
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE TABLET;ORAL Prescription No AB 065131 PAR PHARM
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE TABLET;ORAL Prescription No AB 090217 SUN PHARM INDUSTRIES
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE TABLET;ORAL Prescription No AB 065156 TORRENT

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