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Details for New Drug Application (NDA): 091572

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NDA 091572 describes OLOPATADINE HYDROCHLORIDE, which is a drug marketed by Somerset Theraps Llc, Zach System Spa, Aurobindo Pharma Ltd, Barr Labs Inc, Apotex Inc, and Usv North America, and is included in seven NDAs. It is available from six 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. Thirteen suppliers are listed for this compound. There are six tentative approvals for this compound. Additional details are available on the olopatadine hydrochloride profile page.

Summary for NDA: 091572

Tradename:
OLOPATADINE HYDROCHLORIDE
Applicant:
Apotex Inc
Ingredient:
olopatadine hydrochloride
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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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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