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Details for New Drug Application (NDA): 203152

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NDA 203152 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: 203152

Usv North America
olopatadine hydrochloride
Therapeutic Class:Ophthalmic Agents

Pharmacology for NDA: 203152

Suppliers and Packaging for NDA: 203152

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
olopatadine hydrochloride
SOLUTION/DROPS;OPHTHALMIC 203152 ANDA Rising Pharmaceuticals, Inc. 64980-517 64980-517-05 1 BOTTLE, DROPPER in 1 CARTON (64980-517-05) > 5 mL in 1 BOTTLE, DROPPER

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrengthEQ 0.1% BASE
Approval Date:Dec 7, 2015TE:ATRLD: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.