You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: April 24, 2024

Details for New Drug Application (NDA): 019268

✉ Email this page to a colleague

« Back to Dashboard

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. Fifteen 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
Formulation / Manufacturing:	see details

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

Subscribe to access the full database, or Try a Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	CYTOTEC	misoprostol	TABLET;ORAL	019268-001	Dec 27, 1988	⤷ Try a Trial	⤷ Try a Trial
Pfizer	CYTOTEC	misoprostol	TABLET;ORAL	019268-001	Dec 27, 1988	⤷ Try a Trial	⤷ Try a Trial
Pfizer	CYTOTEC	misoprostol	TABLET;ORAL	019268-003	Sep 21, 1990	⤷ Try a Trial	⤷ Try a Trial
Pfizer	CYTOTEC	misoprostol	TABLET;ORAL	019268-001	Dec 27, 1988	⤷ Try a Trial	⤷ Try a Trial
Pfizer	CYTOTEC	misoprostol	TABLET;ORAL	019268-001	Dec 27, 1988	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.