FDA.reportPublic FDA data

Application 017381

Type
NDA
Sponsor
KING PHARMS LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SILVADENESILVER SULFADIAZINECREAM;TOPICAL1%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
49999-143SILVADENEsilver sulfadiazineLake Erie Medical & Surgical Supply DBA Quality Care Products LLCNDACurrent
50090-0230SILVADENEsilver sulfadiazineA-S Medication SolutionsNDACurrent
50090-0230SILVADENEsilver sulfadiazineA-S Medication SolutionsNDACurrent
50090-0230SILVADENEsilver sulfadiazineA-S Medication SolutionsNDACurrent
50090-0230SILVADENEsilver sulfadiazineA-S Medication SolutionsNDACurrent
59762-0131SILVER SULFADIAZINEsilver sulfadiazineGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0131SILVER SULFADIAZINEsilver sulfadiazineGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0131SILVER SULFADIAZINEsilver sulfadiazineGreenstone LLCNDA AUTHORIZED GENERICCurrent
61570-131SILVADENEsilver sulfadiazinePfizer Laboratories Div Pfizer IncNDACurrent
61570-131SILVADENEsilver sulfadiazinePfizer Laboratories Div Pfizer IncNDACurrent
61570-131SILVADENEsilver sulfadiazinePfizer Laboratories Div Pfizer IncNDACurrent
76413-124SILVADENEsilver sulfadiazineCentral Texas Community Health CentersNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
48137SUPPL2017-04-27
46810SUPPL2017-01-13
33253SUPPL2013-03-08
570SUPPL2013-03-06
13123SUPPL2004-02-03