Details for New Drug Application (NDA): 207183
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The generic ingredient in BUPIVACAINE HYDROCHLORIDE is bupivacaine hydrochloride; epinephrine bitartrate. There are twelve drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the bupivacaine hydrochloride; epinephrine bitartrate profile page.
Summary for 207183
Tradename: | BUPIVACAINE HYDROCHLORIDE |
Applicant: | Eugia Pharma |
Ingredient: | bupivacaine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 207183
Physiological Effect | Local Anesthesia |
Suppliers and Packaging for NDA: 207183
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BUPIVACAINE HYDROCHLORIDE | bupivacaine hydrochloride | INJECTABLE;INJECTION | 207183 | ANDA | A-S Medication Solutions | 50090-4516 | 50090-4516-0 | 50 mL in 1 VIAL, MULTI-DOSE (50090-4516-0) |
BUPIVACAINE HYDROCHLORIDE | bupivacaine hydrochloride | INJECTABLE;INJECTION | 207183 | ANDA | HF Acquisition Co LLC, DBA HealthFirst | 51662-1581 | 51662-1581-3 | 25 POUCH in 1 CASE (51662-1581-3) / 1 VIAL, MULTI-DOSE in 1 POUCH (51662-1581-2) / 50 mL in 1 VIAL, MULTI-DOSE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 0.25% | ||||
Approval Date: | May 13, 2016 | TE: | AP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 0.5% | ||||
Approval Date: | May 13, 2016 | TE: | AP | RLD: | No |
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