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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 three suppliers. There are two patents protecting this drug. 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. Eleven 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. Eleven 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 | INJECTABLE;INJECTION | esmolol hydrochloride | 019386 | 2014-01-31 |
| BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER | INJECTABLE;INJECTION | esmolol hydrochloride | 019386 | 2014-01-31 |
| BREVIBLOC 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 | 019386-007 | May 28, 2003 | Start Trial | Start Trial |
| Baxter Hlthcare | BREVIBLOC | esmolol hydrochloride | INJECTABLE;INJECTION | 019386-003 | Aug 15, 1988 | Start Trial | Start Trial |
| Baxter Hlthcare | BREVIBLOC | esmolol hydrochloride | INJECTABLE;INJECTION | 019386-003 | Aug 15, 1988 | Start Trial | Start Trial |
| Baxter Hlthcare | BREVIBLOC IN PLASTIC CONTAINER | esmolol hydrochloride | INJECTABLE;INJECTION | 019386-004 | Feb 16, 2001 | 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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