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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 217237
Company: TEYRO LABS

Products on ANDA 217237

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CAPECITABINE	CAPECITABINE	150MG	TABLET;ORAL	Prescription	BX	No	No
CAPECITABINE	CAPECITABINE	500MG	TABLET;ORAL	Prescription	BX	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 217237

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/23/2023	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 217237

CAPECITABINE

There are no Therapeutic Equivalents.

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