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Details for New Drug Application (NDA): 018333

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NDA 018333 describes CARAFATE, which is a drug marketed by Forest Labs Inc and is included in two NDAs. It is available from thirteen suppliers. Additional details are available on the CARAFATE profile page.

The generic ingredient in CARAFATE is sucralfate. There are fourteen drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the sucralfate profile page.

Summary for NDA: 018333

Forest Labs Inc
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 018333

Suppliers and Packaging for NDA: 018333

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL 018333 NDA Actavis Pharma, Inc. 0591-0780 0591-0780-01 100 TABLET in 1 BOTTLE, PLASTIC (0591-0780-01)
TABLET;ORAL 018333 NDA Actavis Pharma, Inc. 0591-0780 0591-0780-05 500 TABLET in 1 BOTTLE, PLASTIC (0591-0780-05)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1GM
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

Expired Orange Book Patents for NDA: 018333

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Forest Labs Inc
TABLET;ORAL018333-001Approved Prior to Jan 1, 19823,432,489<disabled>
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