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Last Updated: October 6, 2022

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 three 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
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: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
Pfizer CYTOTEC misoprostol TABLET;ORAL 019268-001 Dec 27, 1988 See Plans and Pricing See Plans and Pricing
Pfizer CYTOTEC misoprostol TABLET;ORAL 019268-003 Sep 21, 1990 See Plans and Pricing See Plans and Pricing
Pfizer CYTOTEC misoprostol TABLET;ORAL 019268-001 Dec 27, 1988 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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