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Last Updated: July 3, 2020

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Details for New Drug Application (NDA): 088810


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NDA 088810 describes PREDNISONE INTENSOL, which is a drug marketed by Hikma and is included in one NDA. It is available from one supplier. Additional details are available on the PREDNISONE INTENSOL profile page.

The generic ingredient in PREDNISONE INTENSOL is prednisone. There are sixteen drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the prednisone profile page.
Summary for 088810
Tradename:PREDNISONE INTENSOL
Applicant:Hikma
Ingredient:prednisone
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 088810
Medical Subject Heading (MeSH) Categories for 088810
Suppliers and Packaging for NDA: 088810
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PREDNISONE INTENSOL prednisone SOLUTION;ORAL 088810 ANDA Hikma Pharmaceuticals USA Inc. 0054-3721 0054-3721-44 30 mL in 1 BOTTLE, DROPPER (0054-3721-44)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength5MG/ML
Approval Date:Feb 20, 1985TE:RLD:No

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Serving leading biopharmaceutical companies globally:

Moodys
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Colorcon
Boehringer Ingelheim
Harvard Business School
Merck

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