Details for New Drug Application (NDA): 217575
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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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