Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065131
Company: STRIDES PHARMA INTL

Products on ANDA 065131

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	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065131

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/16/2003	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
05/11/2012	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/065131s017lbl.pdf
01/19/2010	SUPPL-16	Labeling		Label is not available on this site.
06/30/2008	SUPPL-15	Labeling		Label is not available on this site.
03/17/2005	SUPPL-9	Labeling		Label is not available on this site.
01/05/2004	SUPPL-1	Labeling		Label is not available on this site.

Labels for ANDA 065131

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/11/2012	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/065131s017lbl.pdf

Therapeutic Equivalents for ANDA 065131

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	CHARTWELL RX
MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	TABLET;ORAL	Prescription	No	AB	215466	REGCON HOLDINGS
MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	TABLET;ORAL	Prescription	No	AB	065131	STRIDES PHARMA INTL
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	CHARTWELL RX
MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	TABLET;ORAL	Prescription	No	AB	215466	REGCON HOLDINGS
MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	TABLET;ORAL	Prescription	No	AB	065131	STRIDES PHARMA INTL
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	CHARTWELL RX
MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	215466	REGCON HOLDINGS
MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	065131	STRIDES PHARMA INTL
MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	065156	TORRENT