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.
Pearson Dental
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 HCl
Product Details
NDC Product Code
43305-1030Application Number
ANDA088390Marketing Category
ANDA (C73584)Route of Administration
SUBCUTANEOUSEffective Date
May 15, 2012LidocaineActive
Code: V13007Z41AClass: ACTIBQuantity: 20 mg in 1 mL
EpinephrineActive
Code: 30Q7KI53AKClass: ACTIMQuantity: 0.01 mg in 1 mL
Potassium MetabisulfiteInactive
Code: 65OE787Q7WClass: IACTQuantity: 1.2 mg in 1 mL
Sodium ChlorideInactive
Code: 451W47IQ8XClass: IACTQuantity: 6.5 mg in 1 mL
Sodium HydroxideInactive
Code: 55X04QC32IClass: IACT
Edetate DisodiumInactive
Code: 7FLD91C86KClass: IACTQuantity: 0.25 mg in 1 mL
WaterInactive
Code: 059QF0KO0RClass: IACT