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Generated: November 12, 2018

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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 two suppliers. Additional details are available on the PRELONE profile page.

The generic ingredient in PRELONE is prednisolone. There are eighty-eight drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the prednisolone profile page.
Summary for 089081
Tradename:PRELONE
Applicant:Teva
Ingredient:prednisolone
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 089081
Medical Subject Heading (MeSH) Categories for 089081
Suppliers and Packaging for NDA: 089081
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PRELONE prednisolone SYRUP;ORAL 089081 ANDA Aidarex Pharmaceuticals LLC 33261-475 33261-475-01 240 mL in 1 BOTTLE, PLASTIC (33261-475-01)
PRELONE prednisolone SYRUP;ORAL 089081 ANDA MedVantx, Inc. 66116-603 66116-603-24 240 mL in 1 BOTTLE (66116-603-24)

Profile for product number 001

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

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