Flexible Flat-Rate Plans

Flat-rate pricing for predictable budgeting

Short-term plans for project- or client-based billing

► Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091626

« Back to Dashboard
NDA 091626 describes EPINASTINE HYDROCHLORIDE, which is a drug marketed by Apotex, Sun Pharm Inds, Somerset Theraps Llc, and Breckenridge Pharm, and is included in four NDAs. It is available from four suppliers. Additional details are available on the EPINASTINE HYDROCHLORIDE profile page.

The generic ingredient in EPINASTINE HYDROCHLORIDE is epinastine hydrochloride. There are six drug master file entries for this compound. Five suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the epinastine hydrochloride profile page.

Summary for NDA: 091626

Sun Pharm Inds
epinastine hydrochloride
Therapeutic Class:Ophthalmic Agents

Pharmacology for NDA: 091626

Suppliers and Packaging for NDA: 091626

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
epinastine hydrochloride
SOLUTION/DROPS;OPHTHALMIC 091626 ANDA Sun Pharmaceutical Industries Limited 62756-329 62756-329-90 1 BOTTLE in 1 CARTON (62756-329-90) > 5 mL in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength0.05%
Approval Date:Oct 31, 2011TE:ATRLD:No

Complete Access Available with Subscription
« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

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.