Details for New Drug Application (NDA): 205309
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NDA 205309 describes TIMOLOL, which is a drug marketed by Epic Pharma Llc, Alembic, Amneal, Dr Reddys, Eugia Pharma, Gland Pharma Ltd, Sandoz, Somerset Theraps Llc, Amring Pharms, Apotex, Apotex Inc, Bausch And Lomb, Caplin, Fdc Ltd, Fougera, Hikma, Ingenus Pharms Llc, Mankind Pharma, Micro Labs, Pacific Pharma, Sciegen Pharms Inc, Sentiss Pharma, Somerset, Ani Pharms, Chartwell Rx, Mylan, Quantum Pharmics, Rising, Teva, Usl Pharma, and Watson Labs, and is included in fifty-five NDAs. Additional details are available on the TIMOLOL profile page.
The generic ingredient in TIMOLOL is timolol maleate. There are fifteen drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the timolol maleate profile page.
The generic ingredient in TIMOLOL is timolol maleate. There are fifteen drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the timolol maleate profile page.
Summary for 205309
| Tradename: | TIMOLOL |
| Applicant: | Epic Pharma Llc |
| Ingredient: | timolol |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 205309
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | EQ 0.25% BASE | ||||
| Approval Date: | Sep 30, 2016 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | EQ 0.5% BASE | ||||
| Approval Date: | Sep 30, 2016 | TE: | RLD: | No | |||||
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