Details for New Drug Application (NDA): 019268

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NDA 019268 describes CYTOTEC, which is a drug marketed by Pfizer and is included in one NDA. It is available from four suppliers. Additional details are available on the CYTOTEC profile page.

The generic ingredient in CYTOTEC is misoprostol. There are fourteen drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the misoprostol profile page.

Summary for 019268

Tradename:	CYTOTEC
Applicant:	Pfizer
Ingredient:	misoprostol
Patents:	0

Pharmacology for NDA: 019268

Medical Subject Heading (MeSH) Categories for 019268

Abortifacient Agents, Nonsteroidal
Anti-Ulcer Agents
Oxytocics

Suppliers and Packaging for NDA: 019268

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CYTOTEC	misoprostol	TABLET;ORAL	019268	NDA	Pfizer Laboratories Div Pfizer Inc	0025-1451	0025-1451-34	100 BLISTER PACK in 1 CARTON (0025-1451-34) / 1 TABLET in 1 BLISTER PACK
CYTOTEC	misoprostol	TABLET;ORAL	019268	NDA	Pfizer Laboratories Div Pfizer Inc	0025-1451	0025-1451-60	60 TABLET in 1 BOTTLE, UNIT-DOSE (0025-1451-60)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	0.2MG
Approval Date:	Dec 27, 1988	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	0.1MG
Approval Date:	Sep 21, 1990	TE:	AB	RLD:	Yes

Expired US Patents for NDA 019268

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	CYTOTEC	misoprostol	TABLET;ORAL	019268-001	Dec 27, 1988	⤷ Sign Up	⤷ Sign Up
Pfizer	CYTOTEC	misoprostol	TABLET;ORAL	019268-003	Sep 21, 1990	⤷ Sign Up	⤷ Sign Up
Pfizer	CYTOTEC	misoprostol	TABLET;ORAL	019268-001	Dec 27, 1988	⤷ Sign Up	⤷ Sign Up
Pfizer	CYTOTEC	misoprostol	TABLET;ORAL	019268-001	Dec 27, 1988	⤷ Sign Up	⤷ Sign Up
Pfizer	CYTOTEC	misoprostol	TABLET;ORAL	019268-001	Dec 27, 1988	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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