Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
AVET LIFESCIENCES PRIVATE LIMITED
853181664
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Emcure Pharmaceuticals Limited
NorthStar Rx LLC
AVET LIFESCIENCES PRIVATE LIMITED
675467924
Products3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Furosemide
Product Details
NDC Product Code
72603-474Application Number
ANDA203428Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUSEffective Date
December 27, 2022FurosemideActive
Code: 7LXU5N7ZO5Class: ACTIBQuantity: 10 mg in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
Furosemide
Product Details
NDC Product Code
72603-251Application Number
ANDA203428Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUSEffective Date
December 27, 2022FurosemideActive
Code: 7LXU5N7ZO5Class: ACTIBQuantity: 10 mg in 1 mL
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
Furosemide
Product Details
NDC Product Code
72603-133Application Number
ANDA203428Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUSEffective Date
December 27, 2022FurosemideActive
Code: 7LXU5N7ZO5Class: ACTIBQuantity: 10 mg in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT