Details for New Drug Application (NDA): 211359
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NDA 211359 describes NOREPINEPHRINE BITARTRATE, which is a drug marketed by Amneal, Baxter Hlthcare Corp, Breckenridge, Caplin, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Meitheal, Metrics Pharm, Mylan Labs Ltd, Sandoz, Sun Pharm, Zydus Pharms, Inforlife, and Long Grove Pharms, and is included in seventeen NDAs. It is available from sixteen suppliers. There are seven patents protecting this drug. Additional details are available on the NOREPINEPHRINE BITARTRATE profile page.
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.
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 211359
| Tradename: | NOREPINEPHRINE BITARTRATE |
| Applicant: | Sandoz |
| Ingredient: | norepinephrine bitartrate |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 211359
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NOREPINEPHRINE BITARTRATE | norepinephrine bitartrate | INJECTABLE;INJECTION | 211359 | ANDA | Sandoz Inc | 0781-3755 | 0781-3755-95 | 10 VIAL, SINGLE-DOSE in 1 CARTON (0781-3755-95) / 4 mL in 1 VIAL, SINGLE-DOSE (0781-3755-75) |
| NOREPINEPHRINE BITARTRATE | norepinephrine bitartrate | INJECTABLE;INJECTION | 211359 | ANDA | Civica, Inc. | 72572-481 | 72572-481-10 | 10 VIAL, SINGLE-DOSE in 1 CARTON (72572-481-10) / 4 mL in 1 VIAL, SINGLE-DOSE (72572-481-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 1MG BASE/ML | ||||
| Approval Date: | Oct 18, 2018 | TE: | AP | RLD: | No | ||||
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