Details for New Drug Application (NDA): 084300
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NDA 084300 describes CYCLOMYDRIL, which is a drug marketed by Alcon Labs Inc 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.
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: | Yes | |||||
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