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Generated: November 19, 2017

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Details for New Drug Application (NDA): 208300

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NDA 208300 describes NYSTATIN AND TRIAMCINOLONE ACETONIDE, which is a drug marketed by Glenmark Pharms Ltd, Fougera Pharms Inc, Taro, Alpharma Us Pharms, Akorn, Dr Reddys Labs Ltd, Pharmafair, Perrigo Uk Finco, Perrigo New York, Riconpharma Llc, and Teligent Pharma Inc, and is included in nineteen NDAs. It is available from seventeen suppliers. Additional details are available on the NYSTATIN AND TRIAMCINOLONE ACETONIDE profile page.

The generic ingredient in NYSTATIN AND TRIAMCINOLONE ACETONIDE is nystatin; triamcinolone acetonide. There are eight drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the nystatin; triamcinolone acetonide profile page.

Summary for 208300

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

Pharmacology for NDA: 208300

Ingredient-typePolyenes
Mechanism of ActionCorticosteroid Hormone Receptor Agonists

Suppliers and Packaging for NDA: 208300

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NYSTATIN AND TRIAMCINOLONE ACETONIDE
nystatin; triamcinolone acetonide
OINTMENT;TOPICAL 208300 ANDA Glenmark Pharmaceuticals Inc., USA 68462-799 68462-799-17 1 TUBE in 1 CARTON (68462-799-17) > 15 g in 1 TUBE
NYSTATIN AND TRIAMCINOLONE ACETONIDE
nystatin; triamcinolone acetonide
OINTMENT;TOPICAL 208300 ANDA Glenmark Pharmaceuticals Inc., USA 68462-799 68462-799-35 1 TUBE in 1 CARTON (68462-799-35) > 30 g in 1 TUBE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:OINTMENT;TOPICALStrength100,000 UNITS/GM;0.1%
Approval Date:Jun 23, 2016TE:ATRLD:No


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Serving leading biopharmaceutical companies globally:

Cipla
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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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