Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075340
Company: ENDO OPERATIONS

Products on ANDA 075340

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HYDROXYUREA	HYDROXYUREA	500MG	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075340

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/24/1999	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75340ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/20/2015	SUPPL-11	Labeling-Container/Carton Labels		Label is not available on this site.
02/27/2013	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
10/11/2011	SUPPL-8	Labeling-Container/Carton Labels		Label is not available on this site.
04/11/2011	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
08/15/2006	SUPPL-3	Labeling		Label is not available on this site.
04/11/2002	SUPPL-2	Labeling		Label is not available on this site.
03/27/2001	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 075340

HYDROXYUREA

CAPSULE;ORAL; 500MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
HYDREA	HYDROXYUREA	500MG	CAPSULE;ORAL	Prescription	Yes	AB	016295	CHEPLAPHARM
HYDROXYUREA	HYDROXYUREA	500MG	CAPSULE;ORAL	Prescription	No	AB	075143	BARR
HYDROXYUREA	HYDROXYUREA	500MG	CAPSULE;ORAL	Prescription	No	AB	075340	ENDO OPERATIONS
HYDROXYUREA	HYDROXYUREA	500MG	CAPSULE;ORAL	Prescription	No	AB	213438	LEADING
HYDROXYUREA	HYDROXYUREA	500MG	CAPSULE;ORAL	Prescription	No	AB	218021	QILU