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Generated: December 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022067

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NDA 022067 describes FLO-PRED, which is a drug marketed by Taro and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the FLO-PRED profile page.

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

Summary for 022067

Tradename:1
Applicant:1
Ingredient:1
Patents:4
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Inflammatory Bowel Disease Agents
Ophthalmic Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 022067

Suppliers and Packaging for NDA: 022067

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLO-PRED prednisolone acetate SUSPENSION;ORAL 022067 NDA Taro Pharmaceuticals U.S.A., Inc. 51672-1338 51672-1338-3 1 BOTTLE in 1 CARTON (51672-1338-3) > 52 mL in 1 BOTTLE
FLO-PRED prednisolone acetate SUSPENSION;ORAL 022067 NDA Taro Pharmaceuticals U.S.A., Inc. 51672-1338 51672-1338-5 1 BOTTLE in 1 CARTON (51672-1338-5) > 37 mL in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SUSPENSION;ORALStrengthEQ 5MG BASE/5ML
Approval Date:Jan 17, 2008TE:RLD:No
Patent:► SubscribePatent Expiration:Jun 3, 2018Product Flag?YSubstance Flag?Delist Request?
Patent:► SubscribePatent Expiration:Jun 3, 2018Product Flag?YSubstance Flag?Delist Request?
Patent:► SubscribePatent Expiration:Jun 3, 2018Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 022067

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
TaroFLO-PREDprednisolone acetateSUSPENSION;ORAL022067-002Jan 17, 2008► Subscribe► Subscribe
TaroFLO-PREDprednisolone acetateSUSPENSION;ORAL022067-001Jan 17, 2008► Subscribe► Subscribe
TaroFLO-PREDprednisolone acetateSUSPENSION;ORAL022067-002Jan 17, 2008► Subscribe► Subscribe
TaroFLO-PREDprednisolone acetateSUSPENSION;ORAL022067-001Jan 17, 2008► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Covington
Chubb
Queensland Health
UBS
Argus Health
Mallinckrodt
Boehringer Ingelheim
Johnson and Johnson
Fuji
Julphar

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