An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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

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
03/11/2026	SUPPL-30	Labeling-Package Insert		Label is not available on this site.
08/26/2024	SUPPL-27	Labeling-Package Insert		Label is not available on this site.
08/26/2024	SUPPL-22	Labeling-Package Insert		Label is not available on this site.
08/26/2024	SUPPL-21	Labeling-Package Insert		Label is not available on this site.
08/26/2024	SUPPL-19	Labeling-Package Insert		Label is not available on this site.
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
DOXYCYCLINE	DOXYCYCLINE	EQ 50MG BASE	CAPSULE;ORAL	Prescription	No	AB	065055	STRIDES PHARMA INTL
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
DOXYCYCLINE	DOXYCYCLINE	EQ 100MG BASE	CAPSULE;ORAL	Prescription	No	AB	065055	STRIDES PHARMA INTL
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 INTL
MONODOX	DOXYCYCLINE	EQ 150MG BASE	CAPSULE;ORAL	Prescription	Yes	AB	050641	CHARTWELL RX

Top