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BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Dow
Colorcon
Cerilliant
Daiichi Sankyo
Chubb
Merck
US Army
Express Scripts
UBS
Citi

Generated: December 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091572

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NDA 091572 describes OLOPATADINE HYDROCHLORIDE, which is a drug marketed by Akorn Inc, Apotex Inc, Aurobindo Pharma Ltd, Barr Labs Inc, Cipla Ltd, Somerset Theraps Llc, Usv North America, Wockhardt Ltd, Zambon Spa, and Perrigo Israel, and is included in eleven NDAs. It is available from twelve suppliers. Additional details are available on the OLOPATADINE HYDROCHLORIDE profile page.

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

Summary for 091572

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Ophthalmic Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 091572

Suppliers and Packaging for NDA: 091572

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OLOPATADINE HYDROCHLORIDE olopatadine hydrochloride SPRAY, METERED;NASAL 091572 ANDA Apotex Corp. 60505-0845 60505-0845-5 1 BOTTLE in 1 CARTON (60505-0845-5) > 240 SPRAY, METERED in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SPRAY, METERED;NASALStrength0.665MG/SPRAY
Approval Date:Oct 8, 2014TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Medtronic
Cipla
US Army
Argus Health
US Department of Justice
AstraZeneca
Colorcon
Johnson and Johnson
Express Scripts
Merck

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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