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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065156
Company: TORRENT

Products on ANDA 065156

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065156

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-Container/Carton Labels, Labeling-Package Insert	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.

Therapeutic Equivalents for ANDA 065156

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	215466	BEXIMCO PHARMS USA
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	STRIDES PHARMA
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	215466	BEXIMCO PHARMS USA
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	STRIDES PHARMA
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	215466	BEXIMCO PHARMS USA
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	STRIDES PHARMA
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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