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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208927
Company: BIOCON LTD

Products on ANDA 208927

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PEMETREXED	PEMETREXED	100MG	INJECTABLE;INJECTION	None (Tentative Approval)	None	No	No
PEMETREXED	PEMETREXED	500MG	INJECTABLE;INJECTION	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 208927

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/04/2018	ORIG-1	Tentative Approval		STANDARD		Label is not available on this site.

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