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Details for New Drug Application (NDA): 088295
NDA 088295 describes LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE, which is a drug marketed by Aurobindo Pharma Ltd, Fresenius Kabi Usa, Hospira, Intl Medication, Mylan Labs Ltd, and West-ward Pharms Int, and is included in ten 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. Forty-six 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. Forty-six 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 |
| Formulation / Manufacturing: | see details |
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 | IT3 Medical LLC | 70529-018 | 70529-018-01 | 1 KIT in 1 PACKAGE (70529-018-01) * 50 mL in 1 VIAL, MULTI-DOSE * 1 mL in 1 PACKET * 5 mL in 1 AMPULE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 4% | ||||
| Approval Date: | May 17, 1984 | TE: | RLD: | No | |||||
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