Details for New Drug Application (NDA): 084108
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NDA 084108 describes CYCLOGYL, which is a drug marketed by Alcon Labs Inc and is included in three NDAs. It is available from two suppliers. Additional details are available on the CYCLOGYL profile page.
The generic ingredient in CYCLOGYL is cyclopentolate hydrochloride. There are two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the cyclopentolate hydrochloride profile page.
The generic ingredient in CYCLOGYL is cyclopentolate hydrochloride. There are two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the cyclopentolate hydrochloride profile page.
Summary for 084108
| Tradename: | CYCLOGYL |
| Applicant: | Alcon Labs Inc |
| Ingredient: | cyclopentolate hydrochloride |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 084108
Suppliers and Packaging for NDA: 084108
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CYCLOGYL | cyclopentolate hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 084108 | ANDA | Alcon Laboratories, Inc. | 0065-0397 | 0065-0397-02 | 1 BOTTLE, PLASTIC in 1 CARTON (0065-0397-02) / 2 mL in 1 BOTTLE, PLASTIC |
| CYCLOGYL | cyclopentolate hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 084108 | ANDA | Alcon Laboratories, Inc. | 0065-0397 | 0065-0397-05 | 1 BOTTLE, PLASTIC in 1 CARTON (0065-0397-05) / 5 mL in 1 BOTTLE, PLASTIC |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 2% | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AT | RLD: | Yes | ||||
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