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Serving leading biopharmaceutical companies globally:

Queensland Health
McKesson
QuintilesIMS
Citi
Daiichi Sankyo
Cantor Fitzgerald
Medtronic
Cipla
Healthtrust
McKinsey

Generated: February 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 019268

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NDA 019268 describes CYTOTEC, which is a drug marketed by Gd Searle Llc and is included in one NDA. It is available from eight 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. Twenty suppliers are listed for this compound. Additional details are available on the misoprostol profile page.
Summary for 019268
Tradename:CYTOTEC
Applicant:Gd Searle Llc
Ingredient:misoprostol
Patents:0
Therapeutic Class:Gastrointestinal Agents
Hormonal Agents, Stimulant/Replacement/Modifying (Prostaglandins)
Formulation / Manufacturing:see details
Pharmacology for NDA: 019268
Medical Subject Heading (MeSH) Categories for 019268
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 G.D. Searle LLC Division of Pfizer Inc 0025-1451 N 0025-1451-20
CYTOTEC misoprostol TABLET;ORAL 019268 NDA G.D. Searle LLC Division of Pfizer Inc 0025-1451 N 0025-1451-60

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.2MG
Approval Date:Dec 27, 1988TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.1MG
Approval Date:Sep 21, 1990TE:ABRLD:Yes

Expired US Patents for NDA 019268

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gd Searle Llc CYTOTEC misoprostol TABLET;ORAL 019268-001 Dec 27, 1988 ➤ Try a Free Trial ➤ Try a Free Trial
Gd Searle Llc CYTOTEC misoprostol TABLET;ORAL 019268-001 Dec 27, 1988 ➤ Try a Free Trial ➤ Try a Free Trial
Gd Searle Llc CYTOTEC misoprostol TABLET;ORAL 019268-003 Sep 21, 1990 ➤ Try a Free Trial ➤ Try a Free Trial
Gd Searle Llc CYTOTEC misoprostol TABLET;ORAL 019268-001 Dec 27, 1988 ➤ Try a Free Trial ➤ Try a Free Trial
Gd Searle Llc CYTOTEC misoprostol TABLET;ORAL 019268-001 Dec 27, 1988 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
Fuji
Healthtrust
McKinsey
Dow
Baxter
Mallinckrodt
Queensland Health
Johnson and Johnson

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