FDA.reportPublic FDA data

Application 012623

Type
NDA
Sponsor
GD SEARLE LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FLAGYLMETRONIDAZOLETABLET;ORAL250MGYesNo
003FLAGYLMETRONIDAZOLETABLET;ORAL500MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0025-1821FlagylMetronidazolePfizer Laboratories Div Pfizer IncNDACurrent
0025-1821FlagylMetronidazolePfizer Laboratories Div Pfizer IncNDACurrent
0025-1821FlagylMetronidazoleG.D. Searle LLC Division of Pfizer IncNDACurrent
0025-1821FlagylMetronidazolePfizer Laboratories Div Pfizer IncNDACurrent
0025-1821FlagylMetronidazolePfizer Laboratories Div Pfizer IncNDACurrent
0025-1821FlagylMetronidazoleG.D. Searle LLC Division of Pfizer IncNDACurrent
0025-1821FlagylMetronidazoleG.D. Searle LLC Division of Pfizer IncNDACurrent
0025-1831FlagylMetronidazoleG.D. Searle LLC Division of Pfizer IncNDACurrent
0025-1831FlagylMetronidazoleG.D. Searle LLC Division of Pfizer IncNDACurrent
0025-1831FlagylMetronidazoleG.D. Searle LLC Division of Pfizer IncNDACurrent
67296-1802FlagylMetronidazoleRedPharm DrugNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
79001SUPPL 2024-07-09
78997SUPPL 2024-07-09
75696SUPPL 2023-10-10
75689SUPPL 2023-10-10
69667SUPPL2021-12-20
69596SUPPL2021-12-16
66695SUPPL2021-03-09
66676SUPPL2021-03-09
53623SUPPL2018-04-05
53605SUPPL2018-04-04
33092SUPPL2015-07-16
12029SUPPL2015-07-15
10820SUPPL2013-08-21
338SUPPL2013-08-20
12028SUPPL2010-08-24
33091SUPPL2010-08-20
33090SUPPL2004-04-05
12027SUPPL2004-03-24
10819SUPPL2003-05-28
337SUPPL2003-05-28