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Cipla
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Covington
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Generated: April 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201998

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NDA 201998 describes DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE, which is a drug marketed by Akorn Inc, Apotex Inc, Bausch And Lomb, Hi Tech Pharma, Lannett Holdings Inc, Sandoz, Sandoz Inc, Teva Pharms, Watson Labs Inc, and Zambon Spa, and is included in ten NDAs. It is available from eight suppliers. Additional details are available on the DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE profile page.

The generic ingredient in DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE is dorzolamide hydrochloride; timolol maleate. There are fourteen drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the dorzolamide hydrochloride; timolol maleate profile page.
Summary for 201998
Pharmacology for NDA: 201998
Suppliers and Packaging for NDA: 201998
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE dorzolamide hydrochloride; timolol maleate SOLUTION/DROPS;OPHTHALMIC 201998 ANDA Lannett Company, Inc. 0527-1763 N 0527-1763-73

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION/DROPS;OPHTHALMICStrengthEQ 2% BASE;EQ 0.5% BASE
Approval Date:Dec 17, 2014TE:RLD:No

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Federal Trade Commission
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Colorcon

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