Details for New Drug Application (NDA): 211242
✉ Email this page to a colleague
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 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 |
Complete Access Available with Subscription