Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Emcure Pharmaceuticals Limited
916921919
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Emcure Pharmaceuticals Limited
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Emcure Pharmaceuticals Limited
675467924
Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Amikacin Sulfate
Product Details
NDC Product Code
23155-786Application Number
ANDA204040Marketing Category
ANDA (C73584)Route of Administration
INTRAMUSCULAR, INTRAVENOUSEffective Date
November 17, 2022AmikacinActive
Code: N6M33094FDClass: ACTIMQuantity: 1 g in 4 mL
SODIUM METABISULFITEInactive
Code: 4VON5FNS3CClass: IACT
SULFURIC ACIDInactive
Code: O40UQP6WCFClass: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULRClass: IACT
Amikacin Sulfate
Product Details
NDC Product Code
23155-785Application Number
ANDA204040Marketing Category
ANDA (C73584)Route of Administration
INTRAMUSCULAR, INTRAVENOUSEffective Date
November 17, 2022SODIUM METABISULFITEInactive
Code: 4VON5FNS3CClass: IACT
AmikacinActive
Code: N6M33094FDClass: ACTIMQuantity: 500 mg in 2 mL
SODIUM CITRATEInactive
Code: 1Q73Q2JULRClass: IACT
SULFURIC ACIDInactive
Code: O40UQP6WCFClass: IACT