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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211584
Company: AJANTA PHARMA LTD

Products on ANDA 211584

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET;ORAL	Prescription	AB	No	No
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 211584

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/01/2020	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 211584

DOXYCYCLINE HYCLATE

TABLET;ORAL; EQ 75MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ACTICLATE	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET;ORAL	Prescription	Yes	AB	205931	CHARTWELL RX
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET;ORAL	Prescription	No	AB	211584	AJANTA PHARMA LTD
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET;ORAL	Prescription	No	AB	211744	ALEMBIC
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET;ORAL	Prescription	No	AB	209243	APOTEX
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET;ORAL	Prescription	No	AB	208765	DR REDDYS LABS SA
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET;ORAL	Prescription	No	AB	214207	EPIC PHARMA LLC
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET;ORAL	Prescription	No	AB	208818	LUPIN LTD

TABLET;ORAL; EQ 150MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ACTICLATE	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET;ORAL	Prescription	Yes	AB	205931	CHARTWELL RX
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET;ORAL	Prescription	No	AB	211584	AJANTA PHARMA LTD
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET;ORAL	Prescription	No	AB	211744	ALEMBIC
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET;ORAL	Prescription	No	AB	209243	APOTEX
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET;ORAL	Prescription	No	AB	208765	DR REDDYS LABS SA
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET;ORAL	Prescription	No	AB	214207	EPIC PHARMA LLC
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET;ORAL	Prescription	No	AB	208818	LUPIN LTD

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