Details for New Drug Application (NDA): 088802
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NDA 088802 describes LIDOCAINE VISCOUS, which is a drug marketed by Hikma and is included in one NDA. It is available from five suppliers. Additional details are available on the LIDOCAINE VISCOUS profile page.
The generic ingredient in LIDOCAINE VISCOUS is lidocaine hydrochloride. There are twenty-nine drug master file entries for this compound. Fifty suppliers are listed for this compound. Additional details are available on the lidocaine hydrochloride profile page.
The generic ingredient in LIDOCAINE VISCOUS is lidocaine hydrochloride. There are twenty-nine drug master file entries for this compound. Fifty suppliers are listed for this compound. Additional details are available on the lidocaine hydrochloride profile page.
Summary for 088802
| Tradename: | LIDOCAINE VISCOUS |
| Applicant: | Hikma |
| Ingredient: | lidocaine hydrochloride |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 088802
| Physiological Effect | Local Anesthesia |
Suppliers and Packaging for NDA: 088802
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LIDOCAINE VISCOUS | lidocaine hydrochloride | SOLUTION;ORAL | 088802 | ANDA | Hikma Pharmaceuticals USA Inc. | 0054-3500 | 0054-3500-49 | 1 BOTTLE in 1 CARTON (0054-3500-49) / 100 mL in 1 BOTTLE |
| LIDOCAINE VISCOUS | lidocaine hydrochloride | SOLUTION;ORAL | 088802 | ANDA | Pharmaceutical Associates, Inc. | 0121-0903 | 0121-0903-40 | 4 TRAY in 1 CASE (0121-0903-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE (0121-0903-15) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 2% | ||||
| Approval Date: | Apr 26, 1985 | TE: | AT | RLD: | No | ||||
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