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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065055
Company: STRIDES PHARMA

Products on ANDA 065055

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DOXYCYCLINE	DOXYCYCLINE	EQ 50MG BASE	CAPSULE;ORAL	Prescription	AB	No	No
DOXYCYCLINE	DOXYCYCLINE	EQ 100MG BASE	CAPSULE;ORAL	Prescription	AB	No	No
DOXYCYCLINE	DOXYCYCLINE	EQ 150MG BASE	CAPSULE;ORAL	Prescription	AB	No	Yes
DOXYCYCLINE	DOXYCYCLINE	EQ 75MG BASE	CAPSULE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065055

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/01/2000	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/65055ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/23/2016	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
09/26/2014	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
07/10/2014	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/065055Orig1s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/065055Orig1s013ltr.pdf
12/14/2012	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/065055s012lbl.pdf
04/18/2012	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
03/12/2009	SUPPL-10	Labeling		Label is not available on this site.
04/15/2005	SUPPL-7	Labeling		Label is not available on this site.
07/15/2005	SUPPL-6			Label is not available on this site.
08/01/2005	SUPPL-5	Labeling		Label is not available on this site.
04/18/2005	SUPPL-4	Labeling		Label is not available on this site.
04/18/2005	SUPPL-3			Label is not available on this site.
02/20/2004	SUPPL-2	Labeling		Label is not available on this site.
12/19/2002	SUPPL-1	Labeling		Label is not available on this site.

Labels for ANDA 065055

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/10/2014	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/065055Orig1s013lbl.pdf
12/14/2012	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/065055s012lbl.pdf

Therapeutic Equivalents for ANDA 065055

DOXYCYCLINE

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	DOXYCYCLINE	EQ 50MG BASE	CAPSULE;ORAL	Prescription	No	AB	209396	DR REDDYS LABS SA
DOXYCYCLINE	DOXYCYCLINE	EQ 50MG BASE	CAPSULE;ORAL	Prescription	No	AB	204234	LUPIN LTD
DOXYCYCLINE	DOXYCYCLINE	EQ 50MG BASE	CAPSULE;ORAL	Prescription	No	AB	065055	STRIDES PHARMA
DOXYCYCLINE	DOXYCYCLINE	EQ 50MG BASE	CAPSULE;ORAL	Prescription	No	AB	065053	SUN PHARM INDS LTD
DOXYCYCLINE	DOXYCYCLINE	EQ 50MG BASE	CAPSULE;ORAL	Prescription	No	AB	205115	ZYDUS PHARMS
MONODOX	DOXYCYCLINE	EQ 50MG 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	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

CAPSULE;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	CAPSULE;ORAL	Prescription	No	AB	065055	STRIDES PHARMA
MONODOX	DOXYCYCLINE	EQ 150MG BASE	CAPSULE;ORAL	Prescription	Yes	AB	050641	CHARTWELL RX

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