Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019268
Company: PFIZER

• Other Important Information from FDA

Products on NDA 19268

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CYTOTEC	MISOPROSTOL	0.2MG	TABLET;ORAL	Prescription	AB	Yes	Yes
CYTOTEC	MISOPROSTOL	0.1MG	TABLET;ORAL	Prescription	AB	Yes	No

Labels for NDA 019268

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/28/2018	SUPPL-51	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019268s051lbl.pdf
12/19/2016	SUPPL-49	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019268Orig1s049lbl.pdf
11/19/2012	SUPPL-47	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019268s047lbl.pdf
11/19/2012	SUPPL-47	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019268s047lbl.pdf
09/11/2009	SUPPL-41	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019268s041lbl.pdf
04/17/2002	SUPPL-37	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19268slr037.pdf