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Details for New Drug Application (NDA): 022308
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NDA 022308 describes BESIVANCE, which is a drug marketed by Bausch And Lomb and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the BESIVANCE profile page.
The generic ingredient in BESIVANCE is besifloxacin hydrochloride. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the besifloxacin hydrochloride profile page.
The generic ingredient in BESIVANCE is besifloxacin hydrochloride. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the besifloxacin hydrochloride profile page.
Summary for 022308
| Tradename: | BESIVANCE |
| Applicant: | Bausch And Lomb |
| Ingredient: | besifloxacin hydrochloride |
| Patents: | 5 |
Generic Entry Opportunity Date for 022308
Generic Entry Date for 022308*:
Constraining patent/regulatory exclusivity:
Dosage:
SUSPENSION/DROPS;OPHTHALMIC |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for NDA: 022308
Suppliers and Packaging for NDA: 022308
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BESIVANCE | besifloxacin hydrochloride | SUSPENSION/DROPS;OPHTHALMIC | 022308 | NDA | Bausch & Lomb Incorporated | 24208-446 | 24208-446-02 | 1 BOTTLE, DROPPER in 1 CARTON (24208-446-02) > 2 mL in 1 BOTTLE, DROPPER |
| BESIVANCE | besifloxacin hydrochloride | SUSPENSION/DROPS;OPHTHALMIC | 022308 | NDA | Bausch & Lomb Incorporated | 24208-446 | 24208-446-05 | 1 BOTTLE, DROPPER in 1 CARTON (24208-446-05) > 5 mL in 1 BOTTLE, DROPPER |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION/DROPS;OPHTHALMIC | Strength | EQ 0.6% BASE | ||||
| Approval Date: | May 28, 2009 | TE: | RLD: | Yes | |||||
| Patent: | Start Trial | Patent Expiration: | Jun 29, 2021 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | Start Trial | Patent Expiration: | Nov 7, 2030 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patent: | Start Trial | Patent Expiration: | Jan 9, 2031 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
Expired US Patents for NDA 022308
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Bausch And Lomb | BESIVANCE | besifloxacin hydrochloride | SUSPENSION/DROPS;OPHTHALMIC | 022308-001 | May 28, 2009 | Start Trial | Start Trial |
| Bausch And Lomb | BESIVANCE | besifloxacin hydrochloride | SUSPENSION/DROPS;OPHTHALMIC | 022308-001 | May 28, 2009 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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