Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078587
Company: EMCURE PHARMA

Products on ANDA 078587

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
STAVUDINE	STAVUDINE	40MG	CAPSULE; ORAL	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078587

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/12/2007	ORIG-1	Tentative Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078587s000TA_ltr.pdf