Details for New Drug Application (NDA): 216343
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NDA 216343 describes TIMOLOL MALEATE, which is a drug marketed by Alembic, Amneal, Dr Reddys, Eugia Pharma, Gland, Sandoz, Somerset Theraps Llc, Amring Pharms, Apotex, Apotex Inc, Bausch And Lomb, Caplin, Epic Pharma Llc, Fdc Ltd, Fougera, Hikma, Ingenus Pharms Llc, Mankind Pharma, Micro Labs, Pacific Pharma, Pharmobedient, Sentiss Pharma, Somerset, Ani Pharms, Chartwell Rx, Mylan, Quantum Pharmics, Rising, Teva, Usl Pharma, and Watson Labs, and is included in fifty-four NDAs. It is available from twenty-four suppliers. Additional details are available on the TIMOLOL MALEATE profile page.
The generic ingredient in TIMOLOL MALEATE is timolol maleate. There are fifteen drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the timolol maleate profile page.
The generic ingredient in TIMOLOL MALEATE is timolol maleate. There are fifteen drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the timolol maleate profile page.
Summary for 216343
| Tradename: | TIMOLOL MALEATE |
| Applicant: | Amneal |
| Ingredient: | timolol maleate |
| Patents: | 0 |
Pharmacology for NDA: 216343
| Mechanism of Action | Adrenergic beta-Antagonists |
Suppliers and Packaging for NDA: 216343
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TIMOLOL MALEATE | timolol maleate | SOLUTION, GEL FORMING/DROPS;OPHTHALMIC | 216343 | ANDA | Amneal Pharmaceuticals NY LLC | 60219-1376 | 60219-1376-3 | 1 BOTTLE, DROPPER in 1 CARTON (60219-1376-3) / 5 mL in 1 BOTTLE, DROPPER |
| TIMOLOL MALEATE | timolol maleate | SOLUTION, GEL FORMING/DROPS;OPHTHALMIC | 216343 | ANDA | Amneal Pharmaceuticals NY LLC | 60219-1377 | 60219-1377-3 | 1 BOTTLE, DROPPER in 1 CARTON (60219-1377-3) / 5 mL in 1 BOTTLE, DROPPER |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION, GEL FORMING/DROPS;OPHTHALMIC | Strength | EQ 0.25% BASE | ||||
| Approval Date: | May 23, 2024 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION, GEL FORMING/DROPS;OPHTHALMIC | Strength | EQ 0.5% BASE | ||||
| Approval Date: | May 23, 2024 | TE: | RLD: | No | |||||
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