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Details for New Drug Application (NDA): 018578

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NDA 018578 describes SSD AF, which is a drug marketed by Dr Reddys La and is included in one NDA. It is available from twelve suppliers. Additional details are available on the SSD AF profile page.

The generic ingredient in SSD AF 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 NDA: 018578

Dr Reddys La
silver sulfadiazine
Therapeutic Class:Antibacterials

Pharmacology for NDA: 018578


Suppliers and Packaging for NDA: 018578

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
silver sulfadiazine
CREAM;TOPICAL 018578 NDA Watson Laboratories, Inc. 0591-0810 0591-0810-46 400 g in 1 JAR (0591-0810-46)
silver sulfadiazine
CREAM;TOPICAL 018578 NDA Watson Laboratories, Inc. 0591-0810 0591-0810-55 50 g in 1 JAR (0591-0810-55)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength1%
Approval Date:Feb 25, 1982TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength1%
Approval Date:Jul 11, 1990TE:BXRLD:No

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