Details for New Drug Application (NDA): 211382
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The generic ingredient in NOREPINEPHRINE BITARTRATE is norepinephrine bitartrate. There are five drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the norepinephrine bitartrate profile page.
Summary for 211382
Tradename: | NOREPINEPHRINE BITARTRATE |
Applicant: | Fresenius Kabi Usa |
Ingredient: | norepinephrine bitartrate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 211382
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NOREPINEPHRINE BITARTRATE | norepinephrine bitartrate | INJECTABLE;INJECTION | 211382 | ANDA | Fresenius Kabi USA, LLC | 63323-940 | 63323-940-04 | 10 VIAL, SINGLE-DOSE in 1 CARTON (63323-940-04) / 4 mL in 1 VIAL, SINGLE-DOSE (63323-940-21) |
NOREPINEPHRINE BITARTRATE | norepinephrine bitartrate | INJECTABLE;INJECTION | 211382 | ANDA | Fresenius Kabi USA, LLC | 65219-140 | 65219-140-04 | 10 VIAL, SINGLE-DOSE in 1 CARTON (65219-140-04) / 4 mL in 1 VIAL, SINGLE-DOSE (65219-140-02) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 1MG BASE/ML | ||||
Approval Date: | Nov 3, 2020 | TE: | AP | RLD: | No |
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