Details for New Drug Application (NDA): 214628
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NDA 214628 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 214628
| Tradename: | NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE |
| Applicant: | Long Grove Pharms |
| Ingredient: | norepinephrine bitartrate |
| Patents: | 6 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 214628
| 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 | 214628 | NDA | Long Grove Pharmaceuticals, LLC | 81298-9655 | 81298-9655-3 | 10 POUCH in 1 BOX (81298-9655-3) / 1 BAG in 1 POUCH (81298-9655-1) / 250 mL in 1 BAG |
| NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | norepinephrine bitartrate | SOLUTION;INTRAVENOUS | 214628 | NDA | Long Grove Pharmaceuticals, LLC | 81298-9658 | 81298-9658-3 | 10 POUCH in 1 BOX (81298-9658-3) / 1 BAG in 1 POUCH (81298-9658-1) / 250 mL in 1 BAG |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | EQ 4MG BASE/250 ML (EQ 16MCG BASE/ML) | ||||
| Approval Date: | Oct 6, 2022 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Jan 30, 2038 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Jan 30, 2038 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | INDICATED TO RAISE BLOOD PRESSURE IN ADULT PATIENTS WITH SEVERE, ACUTE HYPOTENSION | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Jan 30, 2038 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | INDICATED TO RAISE BLOOD PRESSURE IN ADULT PATIENTS WITH SEVERE, ACUTE HYPOTENSION | ||||||||
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