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Generated: November 20, 2017

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 Apotex Inc, Sandoz Inc, Teva Pharms, Bausch And Lomb, Hi Tech Pharma, Sandoz, Watson Labs Inc, Akorn Inc, Zambon Spa, and Lannett Holdings Inc, and is included in ten NDAs. It is available from nine 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. Ten suppliers are listed for this compound. Additional details are available on the dorzolamide hydrochloride; timolol maleate profile page.

Summary for 201998

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Formulation / Manufacturing:see details

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

Summary 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 leading biopharmaceutical companies globally:

Novartis
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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