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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211418
Company: MACLEODS PHARMS LTD

Products on ANDA 211418

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 211418

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/19/2025	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 211418

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

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