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Details for New Drug Application (NDA): 088390

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NDA 088390 describes LIGNOSPAN STANDARD, which is a drug marketed by Deproco and is included in one NDA. It is available from twelve suppliers. Additional details are available on the LIGNOSPAN STANDARD profile page.

The generic ingredient in LIGNOSPAN STANDARD is epinephrine bitartrate; lidocaine hydrochloride. There are nineteen drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the epinephrine bitartrate; lidocaine hydrochloride profile page.

Summary for NDA: 088390

epinephrine bitartrate; lidocaine hydrochloride
Formulation / Manufacturing:see details

Pharmacology for NDA: 088390

Suppliers and Packaging for NDA: 088390

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
epinephrine bitartrate; lidocaine hydrochloride
INJECTABLE;INJECTION 088390 ANDA Septodont 0362-9023 0362-9023-05 50 CARTRIDGE in 1 CARTON (0362-9023-05) > 1.7 mL in 1 CARTRIDGE
epinephrine bitartrate; lidocaine hydrochloride
INJECTABLE;INJECTION 088390 ANDA Henry Scein Inc 0404-6512 0404-6512-05 50 CARTRIDGE in 1 CARTON (0404-6512-05) > 1.7 mL in 1 CARTRIDGE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 0.01MG BASE/ML;2%
Approval Date:Jan 22, 1985TE:RLD:No

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