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Generated: September 25, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078223

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NDA 078223 describes CLOBETASOL PROPIONATE, which is a drug marketed by Perrigo Israel, Taro, Ingenus Pharms Llc, Wockhardt, Fougera Pharms, Akorn, Actavis Mid Atlantic, Perrigo Co, G And W Labs Inc, Glenmark Pharms, Mylan Pharms Inc, Teligent Pharma Inc, Novel Labs Inc, Tolmar, Zydus Pharms Usa Inc, Teva Pharms Usa, Fougera Pharms Inc, and Paddock Llc, and is included in thirty-seven NDAs. It is available from twenty-seven suppliers. Additional details are available on the CLOBETASOL PROPIONATE profile page.

The generic ingredient in CLOBETASOL PROPIONATE is clobetasol propionate. There are thirteen drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the clobetasol propionate profile page.

Summary for NDA: 078223

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Formulation / Manufacturing:see details

Pharmacology for NDA: 078223

Suppliers and Packaging for NDA: 078223

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLOBETASOL PROPIONATE
clobetasol propionate
LOTION;TOPICAL 078223 ANDA Actavis Mid Atlantic LLC 0472-0404 0472-0404-91 1 BOTTLE in 1 CARTON (0472-0404-91) > 30 mL in 1 BOTTLE
CLOBETASOL PROPIONATE
clobetasol propionate
LOTION;TOPICAL 078223 ANDA Actavis Mid Atlantic LLC 0472-0404 0472-0404-92 1 BOTTLE in 1 CARTON (0472-0404-92) > 59 mL in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:LOTION;TOPICALStrength0.05%
Approval Date:Dec 4, 2008TE:ABRLD:No


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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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