Details for New Drug Application (NDA): 216533
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NDA 216533 describes TIMOLOL MALEATE, which is a drug marketed by Alembic, Amneal, Dr Reddys, Eugia Pharma, Gland Pharma Ltd, 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, 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-four NDAs. It is available from twenty-five 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-nine 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-nine suppliers are listed for this compound. Additional details are available on the timolol maleate profile page.
Summary for 216533
| Tradename: | TIMOLOL MALEATE |
| Applicant: | Ingenus Pharms Llc |
| Ingredient: | timolol maleate |
| Patents: | 0 |
Pharmacology for NDA: 216533
| Mechanism of Action | Adrenergic beta-Antagonists |
Suppliers and Packaging for NDA: 216533
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TIMOLOL MALEATE | timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 216533 | ANDA | Ingenus Pharmaceuticals, LLC | 50742-287 | 50742-287-60 | 15 POUCH in 1 CARTON (50742-287-60) / 4 CONTAINER in 1 POUCH (50742-287-04) / .3 mL in 1 CONTAINER |
| TIMOLOL MALEATE | timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 216533 | ANDA | Ingenus Pharmaceuticals, LLC | 50742-288 | 50742-288-60 | 15 POUCH in 1 CARTON (50742-288-60) / 4 CONTAINER in 1 POUCH (50742-288-04) / .3 mL in 1 CONTAINER |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | EQ 0.25% BASE | ||||
| Approval Date: | Sep 13, 2022 | TE: | AT3 | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | EQ 0.5% BASE | ||||
| Approval Date: | Sep 13, 2022 | TE: | AT3 | RLD: | No | ||||
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