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Generated: November 21, 2018

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Details for New Drug Application (NDA): 019183

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NDA 019183 describes CARAFATE, which is a drug marketed by Allergan Sales Llc and is included in two NDAs. It is available from twelve 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-seven suppliers are listed for this compound. Additional details are available on the sucralfate profile page.
Summary for 019183
Tradename:CARAFATE
Applicant:Allergan Sales Llc
Ingredient:sucralfate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 019183
Medical Subject Heading (MeSH) Categories for 019183
Suppliers and Packaging for NDA: 019183
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CARAFATE sucralfate SUSPENSION;ORAL 019183 NDA Pharmaceutical Associates, Inc. 0121-0747 0121-0747-00 10 TRAY in 1 CASE (0121-0747-00) > 10 CUP, UNIT-DOSE in 1 TRAY > 10 mL in 1 CUP, UNIT-DOSE (0121-0747-10)
CARAFATE sucralfate SUSPENSION;ORAL 019183 NDA Pharmaceutical Associates, Inc. 0121-0747 0121-0747-40 4 TRAY in 1 CASE (0121-0747-40) > 10 CUP, UNIT-DOSE in 1 TRAY > 10 mL in 1 CUP, UNIT-DOSE (0121-0747-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrength1GM/10ML
Approval Date:Dec 16, 1993TE:RLD:Yes

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