Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Aurobindo Pharma Limited
650082092
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Aurobindo Pharma Limited
Rising Health, LLC
Aurobindo Pharma Limited
918917639
Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Cefprozil
Product Details
NDC Product Code
57237-035Application Number
ANDA065381Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
October 26, 2022ASPARTAMEInactive
Code: Z0H242BBR1Class: IACT
CefprozilActive
Code: 4W0459ZA4VClass: ACTIMQuantity: 250 mg in 5 mL
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMInactive
Code: K679OBS311Class: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQYClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
GLYCINEInactive
Code: TE7660XO1CClass: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1OClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EUClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
Cefprozil
Product Details
NDC Product Code
57237-034Application Number
ANDA065381Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
October 26, 2022CefprozilActive
Code: 4W0459ZA4VClass: ACTIMQuantity: 125 mg in 5 mL
ASPARTAMEInactive
Code: Z0H242BBR1Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMInactive
Code: K679OBS311Class: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQYClass: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1OClass: IACT
GLYCINEInactive
Code: TE7660XO1CClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EUClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT