Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075091
Company: MYLAN

Products on ANDA 75091

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No
CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No

Labels for ANDA 075091

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/30/1999	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75-091_Carbidopa%20and%20Levodopa_prntlbl.pdf