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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208765
Company: DR REDDYS LABS SA

Products on ANDA 208765

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 208765

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/14/2017	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208765Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/30/2023	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
06/30/2023	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
06/30/2023	SUPPL-1	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 208765

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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