Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210537
Company: ALEMBIC

Products on ANDA 210537

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 210537

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/04/2020	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
03/31/2025	SUPPL-9	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 210537

DOXYCYCLINE HYCLATE

TABLET;ORAL; EQ 20MG 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 20MG BASE	TABLET;ORAL	Prescription	No	AB	210537	ALEMBIC
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET;ORAL	Prescription	No	AB	065277	CHARTWELL MOLECULAR
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET;ORAL	Prescription	No	AB	065182	EPIC PHARMA LLC
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET;ORAL	Prescription	No	AB	065287	PHARMOBEDIENT
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET;ORAL	Prescription	No	AB	065134	SUN PHARM INDUSTRIES