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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065062
Company: TORRENT

Products on ANDA 065062

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 065062

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
10/10/2025	SUPPL-31	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
03/06/2025	SUPPL-30	Labeling-Package Insert, Labeling-Patient Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
03/06/2025	SUPPL-24	Labeling-Package Insert		Label is not available on this site.
03/06/2025	SUPPL-22	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
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.

Therapeutic Equivalents for ANDA 065062

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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