Details for New Drug Application (NDA): 084300
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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 084300
Tradename: | CYCLOMYDRIL |
Applicant: | Alcon Labs Inc |
Ingredient: | cyclopentolate hydrochloride; phenylephrine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 084300
Mechanism of Action | Adrenergic 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) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 0.2%;1% | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No |
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