Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065470
Company: AUROBINDO PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE CAPSULE;ORAL Prescription AB No No
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE;ORAL Prescription AB No No
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 100MG 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
03/11/2008 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
04/19/2020 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

04/19/2020 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

04/19/2020 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

04/19/2020 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

08/11/2014 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

10/31/2011 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

09/22/2008 SUPPL-1 Labeling

Label is not available on this site.

MINOCYCLINE HYDROCHLORIDE

CAPSULE;ORAL; EQ 50MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DYNACIN MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE CAPSULE;ORAL Prescription No AB 063067 CNTY LINE PHARMS
MINOCIN MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE CAPSULE;ORAL Prescription Yes AB 050649 BAUSCH
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE CAPSULE;ORAL Prescription No AB 065470 AUROBINDO PHARMA
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE CAPSULE;ORAL Prescription No AB 065005 IMPAX LABS
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE CAPSULE;ORAL Prescription No AB 090867 SUN PHARM INDS INC
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE CAPSULE;ORAL Prescription No AB 065062 TORRENT
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE CAPSULE;ORAL Prescription No AB 063181 WATSON LABS TEVA
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE CAPSULE;ORAL Prescription No AB 063011 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

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

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