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Serving 500+ biopharmaceutical companies globally:

Federal Trade Commission
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Generated: July 26, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 089081

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NDA 089081 describes PRELONE, which is a drug marketed by Muro and Teva and is included in two NDAs. It is available from three suppliers. Additional details are available on the PRELONE profile page.

The generic ingredient in PRELONE is prednisolone. There are eighty-six drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the prednisolone profile page.

Summary for NDA: 089081

Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Inflammatory Bowel Disease Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 089081

Suppliers and Packaging for NDA: 089081

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SYRUP;ORAL 089081 ANDA Teva Pharmaceuticals USA, Inc. 0093-6118 0093-6118-16 1 BOTTLE in 1 CARTON (0093-6118-16) > 480 mL in 1 BOTTLE
SYRUP;ORAL 089081 ANDA Teva Pharmaceuticals USA, Inc. 0093-6118 0093-6118-87 1 BOTTLE in 1 CARTON (0093-6118-87) > 240 mL in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SYRUP;ORALStrength15MG/5ML
Approval Date:Feb 4, 1986TE:AARLD:No

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Serving 500+ biopharmaceutical companies globally:

Queensland Health
Fish and Richardson
Chinese Patent Office
Johnson and Johnson
Boehringer Ingelheim

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