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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065053
Company: SUN PHARM INDS LTD

Products on ANDA 065053

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	Yes
DOXYCYCLINE	DOXYCYCLINE	EQ 75MG BASE	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065053

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/22/2000	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/65053ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/21/2014	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
12/14/2012	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
11/30/2011	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
04/14/2009	SUPPL-14	Labeling		Label is not available on this site.
05/20/2005	SUPPL-9	Labeling		Label is not available on this site.
08/17/2004	SUPPL-7	Labeling		Label is not available on this site.
04/30/2003	SUPPL-6	Labeling		Label is not available on this site.
09/10/2003	SUPPL-5	Labeling		Label is not available on this site.
09/10/2003	SUPPL-4	Manufacturing (CMC)-New Strength		Label is not available on this site.
12/23/2002	SUPPL-3	Labeling		Label is not available on this site.
12/13/2001	SUPPL-2	Manufacturing (CMC)-Packaging		Label is not available on this site.
12/13/2001	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 065053

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 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	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

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