Details for New Drug Application (NDA): 040708
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NDA 040708 describes LIDOCAINE HYDROCHLORIDE VISCOUS, which is a drug marketed by Actavis Mid Atlantic, Chartwell Molecular, Intl Medication, and Pai Holdings Pharm, and is included in four NDAs. It is available from five suppliers. Additional details are available on the LIDOCAINE HYDROCHLORIDE VISCOUS profile page.
The generic ingredient in LIDOCAINE HYDROCHLORIDE VISCOUS is lidocaine hydrochloride. There are twenty-nine drug master file entries for this compound. Fifty-three suppliers are listed for this compound. Additional details are available on the lidocaine hydrochloride profile page.
The generic ingredient in LIDOCAINE HYDROCHLORIDE VISCOUS is lidocaine hydrochloride. There are twenty-nine drug master file entries for this compound. Fifty-three suppliers are listed for this compound. Additional details are available on the lidocaine hydrochloride profile page.
Summary for 040708
| Tradename: | LIDOCAINE HYDROCHLORIDE VISCOUS |
| Applicant: | Chartwell Molecular |
| Ingredient: | lidocaine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 040708
| Physiological Effect | Local Anesthesia |
Suppliers and Packaging for NDA: 040708
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LIDOCAINE HYDROCHLORIDE VISCOUS | lidocaine hydrochloride | SOLUTION;ORAL | 040708 | ANDA | RPK Pharmaceuticals, Inc. | 53002-3431 | 53002-3431-1 | 100 mL in 1 BOTTLE, PLASTIC (53002-3431-1) |
| LIDOCAINE HYDROCHLORIDE VISCOUS | lidocaine hydrochloride | SOLUTION;ORAL | 040708 | ANDA | Chartwell RX, LLC | 62135-712 | 62135-712-42 | 100 mL in 1 BOTTLE (62135-712-42) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 2% | ||||
| Approval Date: | Feb 27, 2007 | TE: | AT | RLD: | No | ||||
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