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Details for New Drug Application (NDA): 091340

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NDA 091340 describes TRAVOPROST, which is a drug marketed by Apotex Inc and Par Pharm and is included in two NDAs. It is available from one supplier. Additional details are available on the TRAVOPROST profile page.

The generic ingredient in TRAVOPROST is travoprost. There are fourteen drug master file entries for this compound. Three suppliers are listed for this compound. There are two tentative approvals for this compound. Additional details are available on the travoprost profile page.

Summary for NDA: 091340

Par Pharm
Therapeutic Class:Ophthalmic Agents

Pharmacology for NDA: 091340


Suppliers and Packaging for NDA: 091340

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SOLUTION/DROPS;OPHTHALMIC 091340 ANDA Par Pharmaceutical, Inc. 49884-044 49884-044-48 1 BOTTLE in 1 CARTON (49884-044-48) > 2.5 mL in 1 BOTTLE
SOLUTION/DROPS;OPHTHALMIC 091340 ANDA Par Pharmaceutical, Inc. 49884-044 49884-044-63 1 BOTTLE in 1 CARTON (49884-044-63) > 5 mL in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength0.004%
Approval Date:Mar 1, 2013TE:RLD:Yes

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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.