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DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: FDC LTD · Approved 2019-06-13
Drug application
- FDA Application #
ANDA205295- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE
- Generic name
- DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE OPHTHALMIC SOLUTION
- Active ingredients
- DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE
- Dosage form
- SOLUTION/DROPS
- Route
- OPHTHALMIC
- Marketing status
- Prescription
- Sponsor
- FDC LTD
- Manufacturer
- Leading Pharma, LLC
- First approval
- 2019-06-13
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown