Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065062
Company: TORRENT
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
11/30/2000 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/65062ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/14/2014 SUPPL-21 Labeling-Package Insert

Label is not available on this site.

05/23/2011 SUPPL-16 Labeling-Package Insert

Label is not available on this site.

11/06/2008 SUPPL-12 Labeling

Label is not available on this site.

03/31/2004 SUPPL-5 Labeling

Label is not available on this site.

02/14/2002 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

02/14/2002 SUPPL-1 Manufacturing (CMC)-Packaging

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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