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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 062538
Company: STRIDES PHARMA INTL

Products on ANDA 062538

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET;ORAL	Prescription	AB	No	No
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 062538

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/07/1986	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
02/06/2026	SUPPL-22	Labeling-Package Insert		Label is not available on this site.
02/06/2026	SUPPL-21	Labeling-Package Insert		Label is not available on this site.
03/31/2025	SUPPL-19	Labeling-Package Insert		Label is not available on this site.
03/27/2025	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
03/27/2025	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
03/27/2025	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
03/16/1993	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
02/23/1991	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
05/08/1989	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 062538

DOXYCYCLINE HYCLATE

TABLET;ORAL; EQ 100MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	210664	ACELLA
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	062421	ACTAVIS LABS FL INC
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	211343	CHANGZHOU PHARM
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	062505	CHARTWELL
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	062269	EPIC PHARMA LLC
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	065095	HIKMA INTL PHARMS
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	211418	MACLEODS PHARMS LTD
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	207558	NOVEL LABS INC
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	062538	STRIDES PHARMA INTL
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	062677	SUN PHARM INDUSTRIES
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	207773	ZYDUS LIFESCIENCES

TABLET;ORAL; EQ 50MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET;ORAL	Prescription	No	AB	210536	ALEMBIC
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET;ORAL	Prescription	No	AB	062505	CHARTWELL
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET;ORAL	Prescription	No	AB	062269	EPIC PHARMA LLC
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET;ORAL	Prescription	No	AB	062538	STRIDES PHARMA INTL

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