Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Novocol Pharmaceutical of Canada, Inc.
Caresteam Health, Inc.
Novocol Pharmaceutical of Canada, Inc.
201719960
Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Carbocaine with Neo-Cobefrin
Product Details
NDC Product Code
31382-931Application Number
ANDA088388Marketing Category
ANDA (C73584)Route of Administration
SUBCUTANEOUSEffective Date
December 12, 2017Edetate disodiumInactive
Code: 7FLD91C86KClass: IACTQuantity: 0.25 mg in 1 mL
Sodium hydroxideInactive
Code: 55X04QC32IClass: IACT
MepivacaineActive
Code: 4VFX2L7EM5Class: ACTIBQuantity: 20 mg in 1 mL
LevonordefrinActive
Code: V008L6478DClass: ACTIBQuantity: 0.05 mg in 1 mL
Sodium chlorideInactive
Code: 451W47IQ8XClass: IACTQuantity: 4 mg in 1 mL
Potassium metabisulfiteInactive
Code: 65OE787Q7WClass: IACTQuantity: 1.2 mg in 1 mL
WaterInactive
Code: 059QF0KO0RClass: IACT
Hydrochloric acidInactive
Code: QTT17582CBClass: IACTQuantity: 0.5 mg in 1 mL
Carbocaine
Product Details
NDC Product Code
31382-753Application Number
ANDA088387Marketing Category
ANDA (C73584)Route of Administration
SUBCUTANEOUSEffective Date
December 12, 2017MepivacaineActive
Code: 4VFX2L7EM5Class: ACTIBQuantity: 30 mg in 1 mL
Sodium chlorideInactive
Code: 451W47IQ8XClass: IACTQuantity: 6 mg in 1 mL
WaterInactive
Code: 059QF0KO0RClass: IACT