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Details for New Drug Application (NDA): 088295
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The generic ingredient in LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE is lidocaine hydrochloride. There are twenty-nine drug master file entries for this compound. Thirty-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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