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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075100
Company: LEK PHARM

Products on ANDA 075100

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BROMOCRIPTINE MESYLATE	BROMOCRIPTINE MESYLATE	EQ 5MG BASE	CAPSULE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075100

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/10/1998	ORIG-1	Approval			Letter (PDF) Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75100ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/75100_Bromocriptine.cfm

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