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Details for New Drug Application (NDA): 020619

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NDA 020619 describes BETOPTIC PILO, which is a drug marketed by Alcon and is included in one NDA. Additional details are available on the BETOPTIC PILO profile page.

The generic ingredient in BETOPTIC PILO is betaxolol hydrochloride; pilocarpine hydrochloride. There are eleven drug master file entries for this compound. Additional details are available on the betaxolol hydrochloride; pilocarpine hydrochloride profile page.

Summary for NDA: 020619

Tradename:
BETOPTIC PILO
Applicant:
Alcon
Ingredient:
betaxolol hydrochloride; pilocarpine hydrochloride
Patents:0
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SUSPENSION/DROPS;OPHTHALMICStrengthEQ 0.25% BASE;1.75%
Approval Date:Apr 17, 1997TE:RLD:No

Expired Orange Book Patents for NDA: 020619

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Alcon
BETOPTIC PILO
betaxolol hydrochloride; pilocarpine hydrochloride
SUSPENSION/DROPS;OPHTHALMIC020619-001Apr 17, 19975,635,172► subscribe
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