Details for New Drug Application (NDA): 216341
✉ Email this page to a colleague
NDA 216341 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 eighteen 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. Twenty-one 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. Twenty-one suppliers are listed for this compound. Additional details are available on the norepinephrine bitartrate profile page.
Summary for 216341
| Tradename: | NOREPINEPHRINE BITARTRATE |
| Applicant: | Zydus Pharms |
| Ingredient: | norepinephrine bitartrate |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 216341
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NOREPINEPHRINE BITARTRATE | norepinephrine bitartrate | INJECTABLE;INJECTION | 216341 | ANDA | Zydus Pharmaceuticals USA Inc. | 70710-1785 | 70710-1785-6 | 10 VIAL, GLASS in 1 CARTON (70710-1785-6) / 4 mL in 1 VIAL, GLASS (70710-1785-1) |
| NOREPINEPHRINE BITARTRATE | norepinephrine bitartrate | INJECTABLE;INJECTION | 216341 | ANDA | Zydus Lifesciences Limited | 70771-1724 | 70771-1724-6 | 10 VIAL, GLASS in 1 CARTON (70771-1724-6) / 4 mL in 1 VIAL, GLASS (70771-1724-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 1MG BASE/ML | ||||
| Approval Date: | Jul 19, 2022 | TE: | RLD: | No | |||||
Complete Access Available with Subscription
