Details for New Drug Application (NDA): 203662
✉ Email this page to a colleague
NDA 203662 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, Rising, Sandoz, Sun Pharm, Zydus Pharms, Inforlife, and Long Grove Pharms, and is included in eighteen NDAs. It is available from nineteen suppliers. There are eight 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-two 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-two suppliers are listed for this compound. Additional details are available on the norepinephrine bitartrate profile page.
Summary for 203662
| Tradename: | NOREPINEPHRINE BITARTRATE |
| Applicant: | Hikma |
| Ingredient: | norepinephrine bitartrate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 203662
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NOREPINEPHRINE BITARTRATE | norepinephrine bitartrate | INJECTABLE;INJECTION | 203662 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9318 | 0143-9318-10 | 10 VIAL in 1 CARTON (0143-9318-10) / 4 mL in 1 VIAL (0143-9318-01) |
| NOREPINEPHRINE BITARTRATE | norepinephrine bitartrate | INJECTABLE;INJECTION | 203662 | ANDA | HF Acquisition Co LLC, DBA HealthFirst | 51662-1528 | 51662-1528-1 | 4 mL in 1 VIAL (51662-1528-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 1MG BASE/ML | ||||
| Approval Date: | Nov 7, 2018 | TE: | AP | RLD: | No | ||||
Complete Access Available with Subscription
