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Generated: November 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 017381

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NDA 017381 describes SILVADENE, which is a drug marketed by King Pharms Llc and is included in one NDA. It is available from four suppliers. Additional details are available on the SILVADENE profile page.

The generic ingredient in SILVADENE is silver sulfadiazine. There are twenty-one drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the silver sulfadiazine profile page.

Summary for 017381

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

Pharmacology for NDA: 017381

Ingredient-typeSulfonamides

Medical Subject Heading (MeSH) Categories for 017381

Suppliers and Packaging for NDA: 017381

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SILVADENE
silver sulfadiazine
CREAM;TOPICAL 017381 NDA Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC 49999-143 49999-143-20 1 TUBE in 1 CARTON (49999-143-20) > 20 g in 1 TUBE
SILVADENE
silver sulfadiazine
CREAM;TOPICAL 017381 NDA A-S Medication Solutions 50090-0230 50090-0230-0 1 TUBE in 1 CARTON (50090-0230-0) > 20 g in 1 TUBE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength1%
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

Expired Orange Book Patents for NDA: 017381

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
King Pharms Llc
SILVADENE
silver sulfadiazine
CREAM;TOPICAL017381-001Approved Prior to Jan 1, 1982► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Novartis
Queensland Health
Colorcon
Citi
Express Scripts
Baxter
US Army
US Department of Justice
Chinese Patent Office
QuintilesIMS

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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