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Generated: December 11, 2017

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Details for New Drug Application (NDA): 200810

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NDA 200810 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 200810

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

Pharmacology for NDA: 200810

Suppliers and Packaging for NDA: 200810

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OLOPATADINE HYDROCHLORIDE olopatadine hydrochloride SOLUTION/DROPS;OPHTHALMIC 200810 ANDA Wockhardt USA LLC. 64679-363 64679-363-01 1 BOTTLE, PLASTIC in 1 CARTON (64679-363-01) > 5 mL in 1 BOTTLE, PLASTIC
OLOPATADINE HYDROCHLORIDE olopatadine hydrochloride SOLUTION/DROPS;OPHTHALMIC 200810 ANDA Jubilant HollisterStier General Partnership 76112-363 76112-363-01 1 BOTTLE, PLASTIC in 1 CARTON (76112-363-01) > 5 mL in 1 BOTTLE, PLASTIC

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrengthEQ 0.1% BASE
Approval Date:Jun 28, 2017TE:ATRLD:No


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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
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Federal Trade Commission
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Chubb

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