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 three suppliers. Additional details are available on the SILVADENE profile page.

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

Summary for 017381

Tradename:	SILVADENE
Applicant:	King Pharms Llc
Ingredient:	silver sulfadiazine
Patents:	0

Pharmacology for NDA: 017381

Medical Subject Heading (MeSH) Categories for 017381

Anti-Infective Agents, Local

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	A-S Medication Solutions	50090-0230	50090-0230-0	1 TUBE in 1 CARTON (50090-0230-0) / 20 g in 1 TUBE
SILVADENE	silver sulfadiazine	CREAM;TOPICAL	017381	NDA AUTHORIZED GENERIC	Greenstone LLC	59762-0131	59762-0131-0	1 TUBE in 1 CARTON (59762-0131-0) / 20 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CREAM;TOPICAL			Strength	1%
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AB	RLD:	Yes

Expired US Patents for NDA 017381

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
King Pharms Llc	SILVADENE	silver sulfadiazine	CREAM;TOPICAL	017381-001	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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