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Fish and Richardson
Mallinckrodt
Citi
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Fuji
Covington
Moodys
Express Scripts
Chubb

Generated: October 23, 2018

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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, Aurobindo Pharma Ltd, Bausch And Lomb, Hi Tech Pharma, Lannett Co Inc, Sandoz, Sandoz Inc, Teva Pharms, Watson Labs Inc, and Zambon Spa, and is included in eleven NDAs. It is available from ten 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. Eleven suppliers are listed for this compound. Additional details are available on the dorzolamide hydrochloride; timolol maleate profile page.
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 0527-1763-73 1 BOTTLE, DROPPER in 1 CARTON (0527-1763-73) > 10 mL in 1 BOTTLE, DROPPER

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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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
Cantor Fitzgerald
Fish and Richardson
Cerilliant
McKinsey
Citi
Mallinckrodt
Queensland Health
Teva

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