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Serving leading biopharmaceutical companies globally:

Farmers Insurance
Fish and Richardson
Argus Health
US Army
US Department of Justice
Federal Trade Commission
Cantor Fitzgerald

Generated: November 18, 2017

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Details for New Drug Application (NDA): 091396

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NDA 091396 describes PREDNISOLONE SODIUM PHOSPHATE, which is a drug marketed by Vintage, Pharm Assoc, Vintage Pharms, Watson Labs, Alcon Pharms Ltd, Amneal Pharms, Medicis Pharms, Akorn, Edenbridge Pharms, Bausch And Lomb, Sola Barnes Hind, Mylan Pharms Inc, We Pharms, Nesher Pharms, Hi Tech Pharma, Chartwell Rx, Wockhardt, and Mission Pharma, and is included in twenty-eight NDAs. It is available from twenty suppliers. Additional details are available on the PREDNISOLONE SODIUM PHOSPHATE profile page.

The generic ingredient in PREDNISOLONE SODIUM PHOSPHATE is prednisolone sodium phosphate. There are eighty-six drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the prednisolone sodium phosphate profile page.

Summary for 091396

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

Pharmacology for NDA: 091396

Suppliers and Packaging for NDA: 091396

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
prednisolone sodium phosphate
SOLUTION;ORAL 091396 ANDA Mission Pharmacal Company 0178-0582 0178-0582-01 30 mL in 1 BOTTLE (0178-0582-01)
prednisolone sodium phosphate
SOLUTION;ORAL 091396 ANDA Mission Pharmacal Company 0178-0582 0178-0582-08 237 mL in 1 BOTTLE (0178-0582-08)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrengthEQ 25MG BASE/5ML
Approval Date:Sep 13, 2010TE:RLD:No

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
US Army
Daiichi Sankyo
Harvard Business School

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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