Details for New Drug Application (NDA): 214336
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The generic ingredient in LIDOCAINE HYDROCHLORIDE is epinephrine; lidocaine hydrochloride. There are twenty-one drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the epinephrine; lidocaine hydrochloride profile page.
Summary for 214336
Tradename: | LIDOCAINE HYDROCHLORIDE |
Applicant: | Aspiro |
Ingredient: | lidocaine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 214336
Physiological Effect | Local Anesthesia |
Suppliers and Packaging for NDA: 214336
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LIDOCAINE HYDROCHLORIDE | lidocaine hydrochloride | INJECTABLE;INJECTION | 214336 | ANDA | Camber Pharmaceuticals, Inc. | 31722-116 | 31722-116-31 | 25 VIAL, MULTI-DOSE in 1 CARTON (31722-116-31) / 20 mL in 1 VIAL, MULTI-DOSE |
LIDOCAINE HYDROCHLORIDE | lidocaine hydrochloride | INJECTABLE;INJECTION | 214336 | ANDA | Camber Pharmaceuticals, Inc. | 31722-116 | 31722-116-32 | 10 VIAL, MULTI-DOSE in 1 CARTON (31722-116-32) / 20 mL in 1 VIAL, MULTI-DOSE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 1% | ||||
Approval Date: | Nov 8, 2021 | TE: | AP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 2% | ||||
Approval Date: | Dec 13, 2023 | TE: | AP | RLD: | No |
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