Details for New Drug Application (NDA): 214313
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NDA 214313 describes NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE, which is a drug marketed by Baxter Hlthcare Corp and Sagent and is included in two NDAs. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE profile page.
The generic ingredient in NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE 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 IN 5% DEXTROSE 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 214313
| Tradename: | NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE |
| Applicant: | Baxter Hlthcare Corp |
| Ingredient: | norepinephrine bitartrate |
| Patents: | 2 |
Suppliers and Packaging for NDA: 214313
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE | norepinephrine bitartrate | SOLUTION;INTRAVENOUS | 214313 | NDA | Baxter Healthcare Corporation | 0338-0108 | 0338-0108-20 | 20 CONTAINER in 1 CARTON (0338-0108-20) / 250 mL in 1 CONTAINER |
| NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE | norepinephrine bitartrate | SOLUTION;INTRAVENOUS | 214313 | NDA | Baxter Healthcare Corporation | 0338-0112 | 0338-0112-20 | 20 BAG in 1 CARTON (0338-0112-20) / 250 mL in 1 BAG |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | EQ 4MG BASE/250ML (EQ 16MCG BASE/ML) | ||||
| Approval Date: | Jan 15, 2021 | TE: | AP | RLD: | Yes | ||||
| Patent: | 12,097,170 | Patent Expiration: | Mar 8, 2041 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TO RESTORE BLOOD PRESSURE IN ADULT PATIENTS WITH ACUTE HYPOTENSIVE STATES | ||||||||
| Patent: | 12,290,494 | Patent Expiration: | Mar 8, 2041 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | EQ 8MG BASE/250ML (EQ 32MCG BASE/ML) | ||||
| Approval Date: | Jan 15, 2021 | TE: | AP | RLD: | Yes | ||||
| Patent: | 12,097,170 | Patent Expiration: | Mar 8, 2041 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TO RESTORE BLOOD PRESSURE IN ADULT PATIENTS WITH ACUTE HYPOTENSIVE STATES | ||||||||
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