Details for New Drug Application (NDA): 215700
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NDA 215700 describes NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE, which is a drug marketed by Inforlife and Long Grove Pharms and is included in two NDAs. It is available from two suppliers. There are seven patents protecting this drug. Additional details are available on the NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE profile page.
The generic ingredient in NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE 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 IN 0.9% SODIUM CHLORIDE 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 215700
| Tradename: | NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE |
| Applicant: | Inforlife |
| Ingredient: | norepinephrine bitartrate |
| Patents: | 1 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 215700
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | norepinephrine bitartrate | SOLUTION;INTRAVENOUS | 215700 | NDA | WG Critical Care, LLC | 44567-640 | 44567-640-10 | 10 BAG in 1 CARTON (44567-640-10) / 250 mL in 1 BAG (44567-640-01) |
| NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | norepinephrine bitartrate | SOLUTION;INTRAVENOUS | 215700 | NDA | WG Critical Care, LLC | 44567-641 | 44567-641-10 | 10 BAG in 1 CARTON (44567-641-10) / 250 mL in 1 BAG (44567-641-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | EQ 4MG BASE/250ML (EQ 16MCG BASE/ML) | ||||
| Approval Date: | Sep 15, 2022 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Apr 26, 2039 | 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: | Sep 15, 2022 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Apr 26, 2039 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | EQ 16MG BASE/250ML (EQ 64MCG BASE/ML) | ||||
| Approval Date: | Sep 15, 2022 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Apr 26, 2039 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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