Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065285
Company: LANNETT CO INC

Products on ANDA 065285

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DOXYCYCLINE	DOXYCYCLINE	EQ 50MG BASE	TABLET;ORAL	Prescription	AB	No	No
DOXYCYCLINE	DOXYCYCLINE	EQ 100MG BASE	TABLET;ORAL	Prescription	AB	No	No
DOXYCYCLINE	DOXYCYCLINE	EQ 75MG BASE	TABLET;ORAL	Prescription	AB	No	No
DOXYCYCLINE	DOXYCYCLINE	EQ 150MG BASE	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065285

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/08/2005	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/02/2014	SUPPL-19	Labeling-Package Insert		Label is not available on this site.
05/08/2015	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
07/30/2008	SUPPL-9	Labeling		Label is not available on this site.
07/30/2008	SUPPL-5	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 065285

DOXYCYCLINE

TABLET;ORAL; EQ 50MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DOXYCYCLINE	DOXYCYCLINE	EQ 50MG BASE	TABLET;ORAL	Prescription	No	AB	091605	HERITAGE PHARMS
DOXYCYCLINE	DOXYCYCLINE	EQ 50MG BASE	TABLET;ORAL	Prescription	No	AB	065285	LANNETT CO INC
DOXYCYCLINE	DOXYCYCLINE	EQ 50MG BASE	TABLET;ORAL	Prescription	No	AB	065070	STRIDES PHARMA
DOXYCYCLINE	DOXYCYCLINE	EQ 50MG BASE	TABLET;ORAL	Prescription	No	AB	065356	SUN PHARM INDS LTD
DOXYCYCLINE	DOXYCYCLINE	EQ 50MG BASE	TABLET;ORAL	Prescription	No	AB	209582	ZYDUS PHARMS

TABLET;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	TABLET;ORAL	Prescription	No	AB	091605	HERITAGE PHARMS
DOXYCYCLINE	DOXYCYCLINE	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	065285	LANNETT CO INC
DOXYCYCLINE	DOXYCYCLINE	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	065070	STRIDES PHARMA
DOXYCYCLINE	DOXYCYCLINE	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	065356	SUN PHARM INDS LTD
DOXYCYCLINE	DOXYCYCLINE	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	209582	ZYDUS PHARMS

TABLET;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	TABLET;ORAL	Prescription	No	AB	091605	HERITAGE PHARMS
DOXYCYCLINE	DOXYCYCLINE	EQ 75MG BASE	TABLET;ORAL	Prescription	No	AB	065285	LANNETT CO INC
DOXYCYCLINE	DOXYCYCLINE	EQ 75MG BASE	TABLET;ORAL	Prescription	No	AB	065070	STRIDES PHARMA
DOXYCYCLINE	DOXYCYCLINE	EQ 75MG BASE	TABLET;ORAL	Prescription	No	AB	065356	SUN PHARM INDS LTD
DOXYCYCLINE	DOXYCYCLINE	EQ 75MG BASE	TABLET;ORAL	Prescription	No	AB	209582	ZYDUS PHARMS

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

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DOXYCYCLINE	DOXYCYCLINE	EQ 150MG BASE	TABLET;ORAL	Prescription	No	AB	091605	HERITAGE PHARMS
DOXYCYCLINE	DOXYCYCLINE	EQ 150MG BASE	TABLET;ORAL	Prescription	No	AB	065285	LANNETT CO INC
DOXYCYCLINE	DOXYCYCLINE	EQ 150MG BASE	TABLET;ORAL	Prescription	No	AB	065070	STRIDES PHARMA
DOXYCYCLINE	DOXYCYCLINE	EQ 150MG BASE	TABLET;ORAL	Prescription	No	AB	065356	SUN PHARM INDS LTD
DOXYCYCLINE	DOXYCYCLINE	EQ 150MG BASE	TABLET;ORAL	Prescription	No	AB	209582	ZYDUS PHARMS