FDA.reportPublic FDA data

Application 020385

Type
NDA
Sponsor
PFIZER INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NICOTROLNICOTINESPRAY, METERED;NASAL0.5MG/SPRAYYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0009-5401NicotrolnicotinePharmacia and Upjohn Company LLCNDACurrent
0009-5401NicotrolnicotinePharmacia & Upjohn Company LLCNDACurrent
0009-5401NicotrolnicotinePharmacia and Upjohn Company LLCNDACurrent
0009-5401NicotrolnicotinePharmacia and Upjohn Company LLCNDACurrent
0009-5401NicotrolnicotinePharmacia and Upjohn Company LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
78556SUPPL 2024-05-24
78550SUPPL 2024-05-24
59892SUPPL2019-09-03
59882SUPPL2019-08-30
34584SUPPL2010-07-01
24879SUPPL2010-07-01
2439SUPPL2004-07-21
2438SUPPL2003-11-25
24878SUPPL2002-09-08