FDA.reportPublic FDA data

Application 050608

Type
NDA
Sponsor
PFIZER

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001UNASYNAMPICILLIN SODIUM; SULBACTAM SODIUMINJECTABLE;INJECTIONEQ 2GM BASE/VIAL;EQ 1GM BASE/VIALYesYes
002UNASYNAMPICILLIN SODIUM; SULBACTAM SODIUMINJECTABLE;INJECTIONEQ 1GM BASE/VIAL;EQ 500MG BASE/VIALYesYes
003UNASYNAMPICILLIN SODIUM; SULBACTAM SODIUMINJECTABLE;INJECTIONEQ 500MG BASE/VIAL;EQ 250MG BASE/VIALNoNo
005UNASYNAMPICILLIN SODIUM; SULBACTAM SODIUMINJECTABLE;INJECTIONEQ 10GM BASE/VIAL;EQ 5GM BASE/VIALYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0049-0013UNASYNampicillin sodium and sulbactam sodiumRoerigNDACurrent
0049-0013UNASYNampicillin sodium and sulbactam sodiumRoerigNDACurrent
0049-0013UNASYNampicillin sodium and sulbactam sodiumRoerigNDACurrent
0049-0013UNASYNampicillin sodium and sulbactam sodiumRoerigNDACurrent
0049-0013UNASYNampicillin sodium and sulbactam sodiumRoerigNDACurrent
0049-0013UNASYNampicillin sodium and sulbactam sodiumRoerigNDACurrent
0049-0014UNASYNampicillin sodium and sulbactam sodiumRoerigNDACurrent
0049-0014UNASYNampicillin sodium and sulbactam sodiumRoerigNDACurrent
0049-0014UNASYNampicillin sodium and sulbactam sodiumRoerigNDACurrent
0049-0014UNASYNampicillin sodium and sulbactam sodiumRoerigNDACurrent
0049-0014UNASYNampicillin sodium and sulbactam sodiumRoerigNDACurrent
0049-0014UNASYNampicillin sodium and sulbactam sodiumRoerigNDACurrent
0049-0022UNASYNampicillin sodium and sulbactam sodiumRoerigNDACurrent
0049-0023UNASYNampicillin sodium and sulbactam sodiumRoerigNDACurrent
0049-0024UNASYNampicillin sodium and sulbactam sodiumRoerigNDACurrent
0049-0024UNASYNampicillin sodium and sulbactam sodiumRoerigNDACurrent
0049-0024UNASYNampicillin sodium and sulbactam sodiumRoerigNDACurrent
0049-0024UNASYNampicillin sodium and sulbactam sodiumRoerigNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84118SUPPL 2025-11-06
84088SUPPL 2025-11-06
81085SUPPL 2025-02-06
81074SUPPL 2025-02-06
78376SUPPL 2024-05-03
78351SUPPL 2024-05-02
64917SUPPL2020-10-14
64896SUPPL2020-10-14
57693ORIG2019-02-15
53779SUPPL2018-04-23
53752SUPPL2018-04-20
47247SUPPL2017-02-16
47197SUPPL2017-02-14
17925SUPPL2014-11-20
17924SUPPL2014-11-20
30162SUPPL2014-11-19
7880SUPPL2014-11-19
7879SUPPL2012-03-13
39036SUPPL2012-03-07
17923SUPPL2008-04-23
30161SUPPL2008-04-16
30160SUPPL2004-08-25
22167SUPPL1997-02-12