Details for New Drug Application (NDA): 020963
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NDA 020963 describes TIMOLOL MALEATE, which is a drug marketed by Alembic, Dr Reddys, Eugia Pharma, Gland Pharma Ltd, Sandoz, Akorn, Amring Pharms, Apotex, Apotex Inc, Bausch And Lomb, Epic Pharma Llc, Fdc Ltd, Fougera, Hikma, Ingenus Pharms Llc, Mankind Pharma, Micro Labs, Pacific Pharma, Sentiss Pharma, Ani Pharms, Chartwell Rx, Mylan, Quantum Pharmics, Rising, Teva, Usl Pharma, and Watson Labs, and is included in forty-nine NDAs. It is available from twenty 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-four 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-four suppliers are listed for this compound. Additional details are available on the timolol maleate profile page.
Summary for 020963
| Tradename: | TIMOLOL MALEATE |
| Applicant: | Sandoz |
| Ingredient: | timolol maleate |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 020963
| Mechanism of Action | Adrenergic beta-Antagonists |
Suppliers and Packaging for NDA: 020963
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TIMOLOL MALEATE | timolol maleate | SOLUTION, GEL FORMING/DROPS;OPHTHALMIC | 020963 | NDA | Sandoz Inc | 61314-224 | 61314-224-05 | 5 mL in 1 BOTTLE (61314-224-05) |
| TIMOLOL MALEATE | timolol maleate | SOLUTION, GEL FORMING/DROPS;OPHTHALMIC | 020963 | NDA | Sandoz Inc | 61314-224 | 61314-224-25 | 2.5 mL in 1 BOTTLE (61314-224-25) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION, GEL FORMING/DROPS;OPHTHALMIC | Strength | EQ 0.25% BASE | ||||
| Approval Date: | Oct 21, 1998 | TE: | AB | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION, GEL FORMING/DROPS;OPHTHALMIC | Strength | EQ 0.5% BASE | ||||
| Approval Date: | Oct 21, 1998 | TE: | AB | RLD: | Yes | ||||
Expired US Patents for NDA 020963
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Sandoz | TIMOLOL MALEATE | timolol maleate | SOLUTION, GEL FORMING/DROPS;OPHTHALMIC | 020963-001 | Oct 21, 1998 | ⤷ Try a Trial | ⤷ Try a Trial |
| Sandoz | TIMOLOL MALEATE | timolol maleate | SOLUTION, GEL FORMING/DROPS;OPHTHALMIC | 020963-002 | Oct 21, 1998 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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