Details for New Drug Application (NDA): 019386
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NDA 019386 describes BREVIBLOC IN PLASTIC CONTAINER, which is a drug marketed by Baxter Hlthcare and is included in one NDA. It is available from four suppliers. Additional details are available on the BREVIBLOC IN PLASTIC CONTAINER profile page.
The generic ingredient in BREVIBLOC 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.
The generic ingredient in BREVIBLOC 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 019386
| Tradename: | BREVIBLOC IN PLASTIC CONTAINER |
| Applicant: | Baxter Hlthcare |
| Ingredient: | esmolol hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 019386
| Mechanism of Action | Adrenergic beta-Antagonists |
Suppliers and Packaging for NDA: 019386
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BREVIBLOC | esmolol hydrochloride | INJECTABLE;INJECTION | 019386 | NDA | Henry Schein, Inc | 0404-9825 | 0404-9825-10 | 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9825-10) / 10 mL in 1 VIAL, SINGLE-DOSE |
| BREVIBLOC | esmolol hydrochloride | INJECTABLE;INJECTION | 019386 | NDA | Baxter Healthcare Corporation | 10019-055 | 10019-055-61 | 10 BAG in 1 CARTON (10019-055-61) / 250 mL in 1 BAG |
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 10MG/ML | ||||
| Approval Date: | Aug 15, 1988 | TE: | RLD: | No | |||||
Profile for product number 004
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 1GM/100ML | ||||
| Approval Date: | Feb 16, 2001 | TE: | AP | RLD: | Yes | ||||
Profile for product number 005
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 2GM/100ML | ||||
| Approval Date: | Jan 27, 2003 | TE: | AP | RLD: | Yes | ||||
Expired US Patents for NDA 019386
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Baxter Hlthcare | BREVIBLOC IN PLASTIC CONTAINER | esmolol hydrochloride | INJECTABLE;INJECTION | 019386-004 | Feb 16, 2001 | ⤷ Sign Up | ⤷ Sign Up |
| Baxter Hlthcare | BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER | esmolol hydrochloride | INJECTABLE;INJECTION | 019386-005 | Jan 27, 2003 | ⤷ Sign Up | ⤷ Sign Up |
| Baxter Hlthcare | BREVIBLOC | esmolol hydrochloride | INJECTABLE;INJECTION | 019386-003 | Aug 15, 1988 | ⤷ Sign Up | ⤷ Sign Up |
| Baxter Hlthcare | BREVIBLOC | esmolol hydrochloride | INJECTABLE;INJECTION | 019386-006 | Feb 25, 2003 | ⤷ Sign Up | ⤷ Sign Up |
| Baxter Hlthcare | BREVIBLOC | esmolol hydrochloride | INJECTABLE;INJECTION | 019386-006 | Feb 25, 2003 | ⤷ Sign Up | ⤷ Sign Up |
| Baxter Hlthcare | BREVIBLOC | esmolol hydrochloride | INJECTABLE;INJECTION | 019386-007 | May 28, 2003 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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