Details for New Drug Application (NDA): 205703
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The generic ingredient in ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER is esmolol hydrochloride. There are eight drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the esmolol hydrochloride profile page.
Summary for 205703
Tradename: | ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER |
Applicant: | Hq Spclt Pharma |
Ingredient: | esmolol hydrochloride |
Patents: | 2 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 205703
Mechanism of Action | Adrenergic beta-Antagonists |
Suppliers and Packaging for NDA: 205703
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER | esmolol hydrochloride | SOLUTION;INTRAVENOUS | 205703 | NDA | WG Critical Care, LLC | 44567-811 | 44567-811-10 | 10 BAG in 1 CARTON (44567-811-10) / 250 mL in 1 BAG |
ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER | esmolol hydrochloride | SOLUTION;INTRAVENOUS | 205703 | NDA | WG Critical Care, LLC | 44567-811 | 44567-811-10 | 10 BAG in 1 CARTON (44567-811-10) / 250 mL in 1 BAG |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 2.5GM/250ML (10MG/ML) | ||||
Approval Date: | Apr 7, 2016 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Mar 15, 2033 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Sign Up | Patent Expiration: | Mar 15, 2033 | Product Flag? | Y | Substance Flag? | Delist Request? |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 2GM/100ML (20MG/ML) | ||||
Approval Date: | Apr 7, 2016 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Mar 15, 2033 | Product Flag? | Y | Substance Flag? | Delist Request? |
Expired US Patents for NDA 205703
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Hq Spclt Pharma | ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER | esmolol hydrochloride | SOLUTION;INTRAVENOUS | 205703-001 | Apr 7, 2016 | ⤷ Sign Up | ⤷ Sign Up |
Hq Spclt Pharma | ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER | esmolol hydrochloride | SOLUTION;INTRAVENOUS | 205703-002 | Apr 7, 2016 | ⤷ Sign Up | ⤷ Sign Up |
Hq Spclt Pharma | ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER | esmolol hydrochloride | SOLUTION;INTRAVENOUS | 205703-002 | Apr 7, 2016 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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