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Federal Trade Commission
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Generated: October 23, 2017

DrugPatentWatch Database Preview

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 nineteen 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 NDA: 074415

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 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 STAT RX USA LLC 16590-523 16590-523-30 30 TABLET in 1 BOTTLE, PLASTIC (16590-523-30)
SUCRALFATE
sucralfate
TABLET;ORAL 074415 ANDA STAT RX USA LLC 16590-523 16590-523-60 60 TABLET in 1 BOTTLE, PLASTIC (16590-523-60)

Summary for product number 001

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


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Serving leading biopharmaceutical companies globally:

Medtronic
Cantor Fitzgerald
Queensland Health
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Chinese Patent Office
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McKinsey
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Moodys

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