Details for New Drug Application (NDA): 217575
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NDA 217575 describes NOREPINEPHRINE BITARTRATE, which is a drug marketed by Amneal, Aspiro, Baxter Hlthcare Corp, Biocon Pharma, Breckenridge, Caplin, Fresenius Kabi Usa, Gland, Hikma, Meitheal, Metrics Pharm, Mylan Labs Ltd, Rising, Sandoz, Sun Pharm, Zydus Pharms, Inforlife, Long Grove Pharms, and Sagent, and is included in twenty-one NDAs. It is available from twenty suppliers. There are thirteen 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-three 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-three suppliers are listed for this compound. Additional details are available on the norepinephrine bitartrate profile page.
Summary for 217575
| Tradename: | NOREPINEPHRINE BITARTRATE |
| Applicant: | Caplin |
| Ingredient: | norepinephrine bitartrate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 217575
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NOREPINEPHRINE BITARTRATE | norepinephrine bitartrate | INJECTABLE;INJECTION | 217575 | ANDA | Caplin Steriles Limited | 65145-133 | 65145-133-10 | 10 VIAL, SINGLE-DOSE in 1 CARTON (65145-133-10) / 4 mL in 1 VIAL, SINGLE-DOSE (65145-133-01) |
| NOREPINEPHRINE BITARTRATE | norepinephrine bitartrate | INJECTABLE;INJECTION | 217575 | ANDA | BE Pharmaceuticals Inc. | 71839-143 | 71839-143-10 | 10 VIAL, SINGLE-DOSE in 1 CARTON (71839-143-10) / 4 mL in 1 VIAL, SINGLE-DOSE (71839-143-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 1MG BASE/ML | ||||
| Approval Date: | Sep 15, 2023 | TE: | AP | RLD: | No | ||||
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