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Details for New Drug Application (NDA): 084109
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NDA 084109 describes CYCLOGYL, which is a drug marketed by Alcon Labs Inc and is included in three NDAs. It is available from three 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. Five 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. Five suppliers are listed for this compound. Additional details are available on the cyclopentolate hydrochloride profile page.
Summary for 084109
| Tradename: | CYCLOGYL |
| Applicant: | Alcon Labs Inc |
| Ingredient: | cyclopentolate hydrochloride |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 084109
Suppliers and Packaging for NDA: 084109
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CYCLOGYL | cyclopentolate hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 084109 | ANDA | Alcon Laboratories, Inc. | 0065-0395 | 0065-0395-15 | 1 BOTTLE, PLASTIC in 1 CARTON (0065-0395-15) > 15 mL in 1 BOTTLE, PLASTIC |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 0.5% | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AT | RLD: | No | ||||
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