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Epinastine hydrochloride - Generic Drug Details

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Epinastine hydrochloride is the generic ingredient in two branded drugs marketed by Apotex, Sun Pharm Inds, Somerset Theraps Llc, Allergan, and Breckenridge Pharm, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

There are six drug master file entries for epinastine hydrochloride. Six suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: epinastine hydrochloride

Tradenames:2
Patents:0
Applicants:5
NDAs:5
Drug Master File Entries: see list6
Suppliers / Packaging: see list6
Therapeutic Class:Ophthalmic Agents
Drug Prices:see low prices

Pharmacology for Ingredient: epinastine hydrochloride

Tentative approvals for EPINASTINE HYDROCHLORIDE

Applicant Application No. Form Dosage
<disabled><disabled>SOLUTION; OPHTHALMIC0.05%
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sun Pharm Inds
EPINASTINE HYDROCHLORIDE
epinastine hydrochloride
SOLUTION/DROPS;OPHTHALMIC091626-001Oct 31, 2011RXNo► subscribe► subscribe
Somerset Theraps Llc
EPINASTINE HYDROCHLORIDE
epinastine hydrochloride
SOLUTION/DROPS;OPHTHALMIC090951-001Oct 31, 2011RXNo► subscribe► subscribe
Breckenridge Pharm
EPINASTINE HYDROCHLORIDE
epinastine hydrochloride
SOLUTION/DROPS;OPHTHALMIC090870-001Mar 14, 2011RXNo► subscribe► subscribe
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