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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207558
Company: NOVEL LABS INC

Products on ANDA 207558

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 207558

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/06/2017	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/02/2020	SUPPL-3	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 207558

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	207773	CADILA
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	062269	CARIBE HOLDINGS
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	065095	HIKMA INTL PHARMS
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	062677	SUN PHARM INDUSTRIES

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