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Serving 500+ biopharmaceutical companies globally:

Accenture
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US Department of Justice
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Generated: June 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204812

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NDA 204812 describes OLOPATADINE HYDROCHLORIDE, which is a drug marketed by Somerset Theraps Llc, Zach System Spa, Aurobindo Pharma Ltd, Akorn Inc, Barr Labs Inc, Apotex Inc, Usv North America, and Perrigo Israel, and is included in nine NDAs. It is available from nine suppliers. Additional details are available on the OLOPATADINE HYDROCHLORIDE profile page.

The generic ingredient in OLOPATADINE HYDROCHLORIDE is olopatadine hydrochloride. There are sixteen drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the olopatadine hydrochloride profile page.

Summary for NDA: 204812

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Ophthalmic Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 204812

Suppliers and Packaging for NDA: 204812

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OLOPATADINE HYDROCHLORIDE
olopatadine hydrochloride
SOLUTION/DROPS;OPHTHALMIC 204812 ANDA Aurobindo Pharma Limited 65862-757 65862-757-05 1 BOTTLE in 1 CARTON (65862-757-05) > 5 mL in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrengthEQ 0.1% BASE
Approval Date:Dec 18, 2015TE:ATRLD:No


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Serving 500+ biopharmaceutical companies globally:

Express Scripts
Queensland Health
Colorcon
Chinese Patent Office
McKinsey
McKesson
US Army
Cerilliant
Boehringer Ingelheim
Fish and Richardson

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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