Details for New Drug Application (NDA): 211242
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The generic ingredient in NOREPINEPHRINE BITARTRATE is norepinephrine bitartrate. There are five drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the norepinephrine bitartrate profile page.
Summary for 211242
Tradename: | NOREPINEPHRINE BITARTRATE |
Applicant: | Mylan Labs Ltd |
Ingredient: | norepinephrine bitartrate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 211242
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NOREPINEPHRINE BITARTRATE | norepinephrine bitartrate | INJECTABLE;INJECTION | 211242 | ANDA | Mylan Institutional LLC | 67457-852 | 67457-852-04 | 10 VIAL, SINGLE-DOSE in 1 CARTON (67457-852-04) / 4 mL in 1 VIAL, SINGLE-DOSE (67457-852-00) |
NOREPINEPHRINE BITARTRATE | norepinephrine bitartrate | INJECTABLE;INJECTION | 211242 | ANDA | Mylan Institutional LLC | 72078-002 | 72078-002-04 | 10 VIAL, SINGLE-DOSE in 1 CARTON (72078-002-04) / 4 mL in 1 VIAL, SINGLE-DOSE (72078-002-00) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 1MG BASE/ML | ||||
Approval Date: | Oct 4, 2018 | TE: | AP | RLD: | No |
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