FDA.reportPublic FDA data

Application 020334

Type
NDA
Sponsor
GD SEARLE LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FLAGYLMETRONIDAZOLECAPSULE;ORAL375MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0025-1942FlagylmetronidazolePfizer Laboratories Div Pfizer IncNDACurrent
0025-1942FlagylmetronidazoleG.D. Searle LLC Division of Pfizer IncNDACurrent
0025-1942FlagylmetronidazolePfizer Laboratories Div Pfizer IncNDACurrent
0025-1942FlagylmetronidazolePfizer Laboratories Div Pfizer IncNDACurrent
0025-1942FlagylmetronidazolePfizer Laboratories Div Pfizer IncNDACurrent
0025-1942FlagylmetronidazoleG.D. Searle LLC Division of Pfizer IncNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
79024SUPPL 2024-07-09
79009SUPPL 2024-07-09
75697SUPPL 2023-10-10
75687SUPPL 2023-10-10
69677SUPPL2021-12-20
69577SUPPL2021-12-16
66689SUPPL2021-03-09
66666SUPPL2021-03-09
53624SUPPL2018-04-05
53604SUPPL2018-04-04
34521SUPPL2015-07-16
2351SUPPL2015-07-14
34520SUPPL2013-08-21
2350SUPPL2013-08-20
24797SUPPL2010-08-24
34519SUPPL2010-08-20
12463SUPPL2004-04-05
24796SUPPL2004-03-24
2349SUPPL2003-05-29
34518SUPPL2003-04-28