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Generated: December 11, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065513

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NDA 065513 describes CLINDAMYCIN PHOSPHATE, which is a drug marketed by Perrigo Uk Finco, Fougera Pharms, Abraxis Pharm, Alvogen Inc, Bedford, Bristol Myers Squibb, Fresenius Kabi Usa, Igi Labs Inc, Loch, Marsam Pharms Llc, Mylan Labs Ltd, Sagent Pharms, Solopak, Teva Parenteral, Watson Labs, West-ward Pharms Int, Boca Pharma Llc, Fougera Pharms Inc, G And W Labs Inc, Novast Labs Ltd, Perrigo New York, Taro Pharm Inds, Teligent Pharma Inc, Vintage Pharms, Wockhardt, Akorn, Actavis Labs Ut Inc, Mylan Pharms Inc, Perrigo Israel, Tolmar, Actavis Mid Atlantic, Baxter Hlthcare Corp, Akorn Inc, Sandoz Inc, Abbvie, and Baxter Hlthcare, and is included in fifty-eight NDAs. It is available from twenty-three suppliers. Additional details are available on the CLINDAMYCIN PHOSPHATE profile page.

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

Summary for 065513

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 065513

Ingredient-typeLincosamides
Physiological EffectDecreased Sebaceous Gland Activity

Suppliers and Packaging for NDA: 065513

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLINDAMYCIN PHOSPHATE clindamycin phosphate SWAB;TOPICAL 065513 ANDA VersaPharm Incorporated 61748-201 61748-201-60 1 JAR in 1 CARTON (61748-201-60) > 60 APPLICATOR in 1 JAR > 1 mL in 1 APPLICATOR

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SWAB;TOPICALStrengthEQ 1% BASE
Approval Date:Jun 17, 2010TE:ATRLD:No


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Serving leading biopharmaceutical companies globally:

Moodys
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Fish and Richardson
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Colorcon

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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