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Generated: January 17, 2019

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Details for New Drug Application (NDA): 074415

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NDA 074415 describes SUCRALFATE, which is a drug marketed by Mylan Ireland Ltd and Teva and is included in two NDAs. It is available from eighteen suppliers. Additional details are available on the SUCRALFATE profile page.

The generic ingredient in SUCRALFATE is sucralfate. There are fourteen drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the sucralfate profile page.
Summary for 074415
Tradename:SUCRALFATE
Applicant:Mylan Ireland Ltd
Ingredient:sucralfate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 074415
Medical Subject Heading (MeSH) Categories for 074415
Suppliers and Packaging for NDA: 074415
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SUCRALFATE sucralfate TABLET;ORAL 074415 ANDA Golden State Medical Supply, Inc. 60429-297 60429-297-01 100 TABLET in 1 BOTTLE, PLASTIC (60429-297-01)
SUCRALFATE sucralfate TABLET;ORAL 074415 ANDA Golden State Medical Supply, Inc. 60429-297 60429-297-05 500 TABLET in 1 BOTTLE (60429-297-05)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength1GM
Approval Date:Jun 8, 1998TE:RLD:No

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