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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 063181
Company: WATSON LABS TEVA

Products on ANDA 063181

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 063181

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/30/1991	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
05/05/2020	SUPPL-54	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
05/05/2020	SUPPL-53	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
05/05/2020	SUPPL-52	Labeling-Package Insert		Label is not available on this site.
11/20/2008	SUPPL-40	Labeling		Label is not available on this site.
05/29/2008	SUPPL-36	Labeling		Label is not available on this site.
10/16/2001	SUPPL-18	Labeling		Label is not available on this site.
10/16/2001	SUPPL-17	Manufacturing (CMC)-Packaging		Label is not available on this site.
04/25/2001	SUPPL-16	Manufacturing (CMC)-Control		Label is not available on this site.
06/07/1999	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
12/09/1998	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
04/07/1998	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
04/07/1998	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
04/07/1998	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
05/12/1998	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
05/12/1998	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
11/05/1997	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
05/08/1996	SUPPL-5	Labeling		Label is not available on this site.
03/04/1996	SUPPL-3	Labeling		Label is not available on this site.
07/22/1992	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 063181

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	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

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