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Details for New Drug Application (NDA): 084300

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NDA 084300 describes CYCLOMYDRIL, which is a drug marketed by Alcon and is included in one NDA. It is available from one supplier. Additional details are available on the CYCLOMYDRIL profile page.

The generic ingredient in CYCLOMYDRIL is cyclopentolate hydrochloride; phenylephrine hydrochloride. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the cyclopentolate hydrochloride; phenylephrine hydrochloride profile page.

Summary for NDA: 084300

Tradename:
CYCLOMYDRIL
Applicant:
Alcon
Ingredient:
cyclopentolate hydrochloride; phenylephrine hydrochloride
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 084300

Mechanism of ActionAdrenergic alpha1-Agonists

Suppliers and Packaging for NDA: 084300

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CYCLOMYDRIL
cyclopentolate hydrochloride; phenylephrine hydrochloride
SOLUTION/DROPS;OPHTHALMIC 084300 ANDA Alcon Laboratories, Inc. 0065-0359 0065-0359-02 2 mL in 1 BOTTLE, PLASTIC (0065-0359-02)
CYCLOMYDRIL
cyclopentolate hydrochloride; phenylephrine hydrochloride
SOLUTION/DROPS;OPHTHALMIC 084300 ANDA Alcon Laboratories, Inc. 0065-0359 0065-0359-05 5 mL in 1 BOTTLE, PLASTIC (0065-0359-05)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength0.2%;1%
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes


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