Details for New Drug Application (NDA): 210839
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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 210839
Tradename: | NOREPINEPHRINE BITARTRATE |
Applicant: | Amneal |
Ingredient: | norepinephrine bitartrate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 210839
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NOREPINEPHRINE BITARTRATE | norepinephrine bitartrate | INJECTABLE;INJECTION | 210839 | ANDA | Amneal Pharmaceuticals LLC | 70121-1576 | 70121-1576-7 | 10 VIAL in 1 CARTON (70121-1576-7) / 4 mL in 1 VIAL (70121-1576-1) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 1MG BASE/ML | ||||
Approval Date: | Dec 17, 2018 | TE: | AP | RLD: | No |
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