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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 ten 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 NDA: 019268

Pharmacology for NDA: 019268

Suppliers and Packaging for NDA: 019268

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL 019268 NDA G.D. Searle LLC Division of Pfizer Inc 0025-1451 0025-1451-20 120 TABLET in 1 BOTTLE, UNIT-DOSE (0025-1451-20)
TABLET;ORAL 019268 NDA G.D. Searle LLC Division of Pfizer Inc 0025-1451 0025-1451-34 100 BLISTER PACK in 1 CARTON (0025-1451-34) > 1 TABLET in 1 BLISTER PACK

Summary for product number 001

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

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.1MG
Approval Date:Sep 21, 1990TE:ABRLD:No

Expired Orange Book Patents for NDA: 019268

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gd Searle Llc
TABLET;ORAL019268-001Dec 27, 19884,459,310<disabled>
Gd Searle Llc
TABLET;ORAL019268-003Sep 21, 19904,301,146<disabled>
Gd Searle Llc
TABLET;ORAL019268-001Dec 27, 19884,060,691<disabled>
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