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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210527
Company: ALEMBIC

Products on ANDA 210527

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 210527

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/13/2018	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
10/25/2024	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
10/25/2024	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 210527

DOXYCYCLINE HYCLATE

CAPSULE;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	CAPSULE;ORAL	Prescription	No	AB	062031	ACTAVIS LABS FL INC
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE;ORAL	Prescription	No	AB	210527	ALEMBIC
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE;ORAL	Prescription	No	AB	062500	CHARTWELL
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE;ORAL	Prescription	No	AB	062396	HIKMA INTL PHARMS
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE;ORAL	Prescription	No	AB	062337	STRIDES PHARMA
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE;ORAL	Prescription	No	AB	062676	SUN PHARM INDUSTRIES
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE;ORAL	Prescription	No	AB	207774	ZYDUS LIFESCIENCES

CAPSULE;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	CAPSULE;ORAL	Prescription	No	AB	062031	ACTAVIS LABS FL INC
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE;ORAL	Prescription	No	AB	210527	ALEMBIC
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE;ORAL	Prescription	No	AB	207289	AMNEAL PHARMS
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE;ORAL	Prescription	No	AB	209402	CHANGZHOU PHARM
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE;ORAL	Prescription	No	AB	062500	CHARTWELL
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE;ORAL	Prescription	No	AB	062396	HIKMA INTL PHARMS
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE;ORAL	Prescription	No	AB	211137	MACLEODS PHARMS LTD
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE;ORAL	Prescription	No	AB	062337	STRIDES PHARMA
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE;ORAL	Prescription	No	AB	062676	SUN PHARM INDUSTRIES
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE;ORAL	Prescription	No	AB	207774	ZYDUS LIFESCIENCES

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