Details for New Drug Application (NDA): 088295
NDA 088295 describes LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE, which is a drug marketed by Chartwell Rx, Eugia Pharma, Fresenius Kabi Usa, Hikma, Hospira, and Intl Medication, 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 is one drug master file entry for this compound. Fifty-seven 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 is one drug master file entry for this compound. Fifty-seven suppliers are listed for this compound. Additional details are available on the lidocaine hydrochloride profile page.
Summary for 088295
| Tradename: | LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE |
| Applicant: | Hospira |
| Ingredient: | lidocaine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 088295
| Physiological Effect | Local Anesthesia |
Suppliers and Packaging for NDA: 088295
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE | lidocaine hydrochloride | INJECTABLE;INJECTION | 088295 | ANDA | Hospira, Inc. | 0409-4283 | 0409-4283-01 | 5 CELLO PACK in 1 PACKAGE (0409-4283-01) / 5 AMPULE in 1 CELLO PACK (0409-4283-25) / 5 mL in 1 AMPULE (0409-4283-11) |
| LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE | lidocaine hydrochloride | INJECTABLE;INJECTION | 088295 | ANDA | Hospira, Inc. | 0409-4283 | 0409-4283-15 | 5 CELLO PACK in 1 CARTON (0409-4283-15) / 5 AMPULE in 1 CELLO PACK (0409-4283-10) / 5 mL in 1 AMPULE (0409-4283-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 4% | ||||
| Approval Date: | May 17, 1984 | TE: | AP | RLD: | No | ||||
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