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Details for New Drug Application (NDA): 019386
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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: | 2 |
Formulation / Manufacturing: | see details |
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 | Baxter Healthcare Corporation | 10019-055 | 10019-055-61 | 10 BAG in 1 CARTON (10019-055-61) > 250 mL in 1 BAG |
BREVIBLOC | esmolol hydrochloride | INJECTABLE;INJECTION | 019386 | NDA | Baxter Healthcare Corporation | 10019-075 | 10019-075-87 | 10 BAG in 1 CARTON (10019-075-87) > 100 mL in 1 BAG |
Paragraph IV (Patent) Challenges for 019386
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
BREVIBLOC IN PLASTIC CONTAINER | INJECTABLE;INJECTION | esmolol hydrochloride | 019386 | 2014-01-31 |
BREVIBLOC | INJECTABLE;INJECTION | esmolol hydrochloride | 019386 | 2014-01-31 |
BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER | INJECTABLE;INJECTION | esmolol hydrochloride | 019386 | 2014-01-31 |
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: | RLD: | Yes | |||||
Patent: | Start Trial | Patent Expiration: | Jul 12, 2021 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Patent: | Start Trial | Patent Expiration: | Jul 12, 2021 | Product Flag? | Substance Flag? | Delist Request? | Y |
Expired US Patents for NDA 019386
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Baxter Hlthcare | BREVIBLOC | esmolol hydrochloride | INJECTABLE;INJECTION | 019386-003 | Aug 15, 1988 | Start Trial | Start Trial |
Baxter Hlthcare | BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER | esmolol hydrochloride | INJECTABLE;INJECTION | 019386-005 | Jan 27, 2003 | Start Trial | Start Trial |
Baxter Hlthcare | BREVIBLOC | esmolol hydrochloride | INJECTABLE;INJECTION | 019386-007 | May 28, 2003 | Start Trial | Start Trial |
Baxter Hlthcare | BREVIBLOC | esmolol hydrochloride | INJECTABLE;INJECTION | 019386-006 | Feb 25, 2003 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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