Details for New Drug Application (NDA): 091487
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The generic ingredient in BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE is bupivacaine hydrochloride. There are twelve drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the bupivacaine hydrochloride profile page.
Summary for 091487
Tradename: | BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE |
Applicant: | Steriscience Speclts |
Ingredient: | bupivacaine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 091487
Physiological Effect | Local Anesthesia |
Suppliers and Packaging for NDA: 091487
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE | bupivacaine hydrochloride | INJECTABLE;INJECTION | 091487 | ANDA | Xellia Pharmaceuticals USA LLC | 70594-114 | 70594-114-02 | 10 VIAL in 1 CARTON (70594-114-02) / 10 mL in 1 VIAL (70594-114-01) |
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE | bupivacaine hydrochloride | INJECTABLE;INJECTION | 091487 | ANDA | Xellia Pharmaceuticals USA LLC | 70594-115 | 70594-115-01 | 30 mL in 1 VIAL, SINGLE-DOSE (70594-115-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 0.5% | ||||
Approval Date: | Oct 18, 2011 | TE: | AP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 0.25% | ||||
Approval Date: | Oct 18, 2011 | TE: | AP | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 0.75% | ||||
Approval Date: | Oct 18, 2011 | TE: | AP | RLD: | No |
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