Details for New Drug Application (NDA): 085555
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NDA 085555 describes AK-PENTOLATE, which is a drug marketed by Epic Pharma Llc and is included in one NDA. Additional details are available on the AK-PENTOLATE profile page.
The generic ingredient in AK-PENTOLATE 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 AK-PENTOLATE 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 085555
| Tradename: | AK-PENTOLATE |
| Applicant: | Epic Pharma Llc |
| Ingredient: | cyclopentolate hydrochloride |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 085555
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 1% | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
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