Details for New Drug Application (NDA): 080408
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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. Fifty suppliers are listed for this compound. Additional details are available on the lidocaine hydrochloride profile page.
Summary for 080408
Tradename: | LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE |
Applicant: | Hospira |
Ingredient: | lidocaine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 080408
Physiological Effect | Local Anesthesia |
Suppliers and Packaging for NDA: 080408
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE | lidocaine hydrochloride | INJECTABLE;INJECTION | 080408 | ANDA | Henry Schein, Inc. | 0404-9887 | 0404-9887-02 | 1 AMPULE in 1 BAG (0404-9887-02) / 2 mL in 1 AMPULE |
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE | lidocaine hydrochloride | INJECTABLE;INJECTION | 080408 | ANDA | Hospira, Inc. | 0409-4713 | 0409-4713-02 | 5 CELLO PACK in 1 PACKAGE (0409-4713-02) / 5 AMPULE in 1 CELLO PACK (0409-4713-26) / 5 mL in 1 AMPULE (0409-4713-12) |
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 | 1.5% | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AP | RLD: | No |
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