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Details for New Drug Application (NDA): 084109
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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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