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Generated: November 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 050793

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NDA 050793 describes CLINDESSE, which is a drug marketed by Perrigo Pharma Intl and is included in one NDA. It is available from two suppliers. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the CLINDESSE profile page.

The generic ingredient in CLINDESSE is clindamycin phosphate. There are fifty-three drug master file entries for this compound. Thirty-three suppliers are listed for this compound. Additional details are available on the clindamycin phosphate profile page.

Summary for 050793

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:2
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 050793

Ingredient-typeLincosamides
Physiological EffectDecreased Sebaceous Gland Activity

Suppliers and Packaging for NDA: 050793

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLINDESSE
clindamycin phosphate
CREAM;VAGINAL 050793 NDA Perrigo New York Inc 45802-042 45802-042-01 1 APPLICATOR in 1 CARTON (45802-042-01) > 5 g in 1 APPLICATOR
CLINDESSE
clindamycin phosphate
CREAM;VAGINAL 050793 NDA Perrigo New York Inc 45802-042 45802-042-02 1 APPLICATOR in 1 CARTON (45802-042-02) > 5 g in 1 APPLICATOR

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;VAGINALStrengthEQ 2% BASE
Approval Date:Nov 30, 2004TE:RLD:Yes
Patent:► SubscribePatent Expiration:Nov 17, 2017Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD OF TREATING BACTERIAL VAGINOSIS
Patent:► SubscribePatent Expiration:Apr 27, 2023Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD OF TREATING BACTERIAL VAGINOSIS

Expired Orange Book Patents for NDA: 050793

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Perrigo Pharma Intl
CLINDESSE
clindamycin phosphate
CREAM;VAGINAL050793-001Nov 30, 2004► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Colorcon
Julphar
Dow
QuintilesIMS
Cantor Fitzgerald
Chinese Patent Office
Mallinckrodt
UBS
Daiichi Sankyo

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