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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065470
Company: AUROBINDO PHARMA

Products on ANDA 065470

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065470

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
02/04/2025	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
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.

Therapeutic Equivalents for ANDA 065470

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
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	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
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	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
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	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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