Details for New Drug Application (NDA): 205703
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NDA 205703 describes ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER, which is a drug marketed by Hq Spclt Pharma and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER profile page.
The generic ingredient in ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER is esmolol hydrochloride. There are eight drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the esmolol hydrochloride profile page.
The generic ingredient in ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER is esmolol hydrochloride. There are eight drug master file entries for this compound. Fourteen 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 |
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: | ⤷ Get Started Free | Patent Expiration: | Mar 15, 2033 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Get Started Free | 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: | ⤷ Get Started Free | 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 DOUBLE STRENGTH IN PLASTIC CONTAINER | esmolol hydrochloride | SOLUTION;INTRAVENOUS | 205703-002 | Apr 7, 2016 | ⤷ Get Started Free | ⤷ Get Started Free |
| Hq Spclt Pharma | ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER | esmolol hydrochloride | SOLUTION;INTRAVENOUS | 205703-001 | Apr 7, 2016 | ⤷ Get Started Free | ⤷ Get Started Free |
| Hq Spclt Pharma | ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER | esmolol hydrochloride | SOLUTION;INTRAVENOUS | 205703-001 | Apr 7, 2016 | ⤷ Get Started Free | ⤷ Get Started Free |
| Hq Spclt Pharma | ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER | esmolol hydrochloride | SOLUTION;INTRAVENOUS | 205703-002 | Apr 7, 2016 | ⤷ Get Started Free | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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