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.
Novocol Pharmaceutical of Canada, Inc.
Novocol Pharmaceutical of Canada, Inc.
201719960
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Lidocaine
Product Details
NDC Product Code
51004-0550Application Number
ANDA088389Marketing Category
ANDA (C73584)Route of Administration
SUBCUTANEOUSEffective Date
December 15, 2011LidocaineActive
Code: V13007Z41AClass: ACTIBQuantity: 20 mg in 1 mL
EpinephrineActive
Code: 30Q7KI53AKClass: ACTIMQuantity: 0.02 mg in 1 mL
Sodium ChlorideInactive
Code: 451W47IQ8XClass: IACTQuantity: 6.5 mg in 1 mL
Potassium MetabisulfiteInactive
Code: 65OE787Q7WClass: IACTQuantity: 1.2 mg in 1 mL
Edetate DisodiumInactive
Code: 7FLD91C86KClass: IACTQuantity: 0.25 mg in 1 mL
Sodium HydroxideInactive
Code: 55X04QC32IClass: IACT
WaterInactive
Code: 059QF0KO0RClass: IACT