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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209165
Company: ALEMBIC

Products on ANDA 209165

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DOXYCYCLINE	DOXYCYCLINE	EQ 75MG BASE	CAPSULE;ORAL	Prescription	AB	No	No
DOXYCYCLINE	DOXYCYCLINE	EQ 100MG BASE	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 209165

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/28/2017	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
01/25/2021	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
01/25/2021	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 209165

DOXYCYCLINE

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

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DOXYCYCLINE	DOXYCYCLINE	EQ 75MG BASE	CAPSULE;ORAL	Prescription	No	AB	209165	ALEMBIC
DOXYCYCLINE	DOXYCYCLINE	EQ 75MG BASE	CAPSULE;ORAL	Prescription	No	AB	204446	COSETTE
DOXYCYCLINE	DOXYCYCLINE	EQ 75MG BASE	CAPSULE;ORAL	Prescription	No	AB	209396	DR REDDYS LABS SA
DOXYCYCLINE	DOXYCYCLINE	EQ 75MG BASE	CAPSULE;ORAL	Prescription	No	AB	204234	LUPIN LTD
DOXYCYCLINE	DOXYCYCLINE	EQ 75MG BASE	CAPSULE;ORAL	Prescription	No	AB	065053	SUN PHARM INDS LTD
DOXYCYCLINE	DOXYCYCLINE	EQ 75MG BASE	CAPSULE;ORAL	Prescription	No	AB	205115	ZYDUS PHARMS
MONODOX	DOXYCYCLINE	EQ 75MG BASE	CAPSULE;ORAL	Prescription	Yes	AB	050641	CHARTWELL RX

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	DOXYCYCLINE	EQ 100MG BASE	CAPSULE;ORAL	Prescription	No	AB	209165	ALEMBIC
DOXYCYCLINE	DOXYCYCLINE	EQ 100MG BASE	CAPSULE;ORAL	Prescription	No	AB	204446	COSETTE
DOXYCYCLINE	DOXYCYCLINE	EQ 100MG BASE	CAPSULE;ORAL	Prescription	No	AB	209396	DR REDDYS LABS SA
DOXYCYCLINE	DOXYCYCLINE	EQ 100MG BASE	CAPSULE;ORAL	Prescription	No	AB	204234	LUPIN LTD
DOXYCYCLINE	DOXYCYCLINE	EQ 100MG BASE	CAPSULE;ORAL	Prescription	No	AB	065055	STRIDES PHARMA
DOXYCYCLINE	DOXYCYCLINE	EQ 100MG BASE	CAPSULE;ORAL	Prescription	No	AB	065053	SUN PHARM INDS LTD
DOXYCYCLINE	DOXYCYCLINE	EQ 100MG BASE	CAPSULE;ORAL	Prescription	No	AB	205115	ZYDUS PHARMS
MONODOX	DOXYCYCLINE	EQ 100MG BASE	CAPSULE;ORAL	Prescription	Yes	AB	050641	CHARTWELL RX

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