Details for New Drug Application (NDA): 088389
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NDA 088389 describes LIGNOSPAN FORTE, which is a drug marketed by Deproco and is included in one NDA. It is available from six suppliers. Additional details are available on the LIGNOSPAN FORTE profile page.
The generic ingredient in LIGNOSPAN FORTE is epinephrine bitartrate; lidocaine hydrochloride. There are twenty-one drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the epinephrine bitartrate; lidocaine hydrochloride profile page.
The generic ingredient in LIGNOSPAN FORTE is epinephrine bitartrate; lidocaine hydrochloride. There are twenty-one drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the epinephrine bitartrate; lidocaine hydrochloride profile page.
Summary for 088389
| Tradename: | LIGNOSPAN FORTE |
| Applicant: | Deproco |
| Ingredient: | epinephrine bitartrate; lidocaine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 088389
| Mechanism of Action | Adrenergic alpha-Agonists Adrenergic beta-Agonists |
| Physiological Effect | Local Anesthesia |
Suppliers and Packaging for NDA: 088389
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LIGNOSPAN FORTE | epinephrine bitartrate; lidocaine hydrochloride | INJECTABLE;INJECTION | 088389 | ANDA | Septodont, Inc. | 0362-0262 | 0362-0262-05 | 50 CARTRIDGE in 1 CARTON (0362-0262-05) / 1.7 mL in 1 CARTRIDGE |
| LIGNOSPAN FORTE | epinephrine bitartrate; lidocaine hydrochloride | INJECTABLE;INJECTION | 088389 | ANDA | Septodont, Inc. | 0362-1096 | 0362-1096-70 | 5 BLISTER PACK in 1 CARTON (0362-1096-70) / 10 CARTRIDGE in 1 BLISTER PACK / 1.7 mL in 1 CARTRIDGE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 0.02MG BASE/ML;2% | ||||
| Approval Date: | Jan 22, 1985 | TE: | RLD: | Yes | |||||
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