Details for New Drug Application (NDA): 084625
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NDA 084625 describes LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE, which is a drug marketed by Eugia Pharma, Fresenius Kabi Usa, Hikma, Hospira, Intl Medication, and Rising, and is included in nine NDAs. It is available from eleven suppliers. Additional details are available on the LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE profile page.
The generic ingredient in LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE 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 PRESERVATIVE FREE 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 084625
| Tradename: | LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE |
| Applicant: | Hikma |
| Ingredient: | lidocaine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 084625
| Physiological Effect | Local Anesthesia |
Suppliers and Packaging for NDA: 084625
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE | lidocaine hydrochloride | INJECTABLE;INJECTION | 084625 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9594 | 0143-9594-25 | 25 VIAL, SINGLE-DOSE in 1 CARTON (0143-9594-25) / 5 mL in 1 VIAL, SINGLE-DOSE (0143-9594-01) |
| LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE | lidocaine hydrochloride | INJECTABLE;INJECTION | 084625 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9595 | 0143-9595-25 | 25 VIAL, SINGLE-DOSE in 1 CARTON (0143-9595-25) / 5 mL in 1 VIAL, SINGLE-DOSE (0143-9595-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 1% | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 2% | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AP | RLD: | No | ||||
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