Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021396
Company: WYETH AYERST

Products on NDA 21396

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PREMPRO/PREMPHASE	CONJUGATED ESTROGENS/MEDROXYPROGESTERONE ACETATE	0.45MG/1.5MG & 0.3MG/1.5MG	Tablet; Oral	Prescription	None	No	No

Labels for NDA 021396

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/04/2003	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21396_prempro_lbl.pdf