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Details for New Drug Application (NDA): 206127

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NDA 206127 describes EPTIFIBATIDE, which is a drug marketed by Aurobindo Pharma Ltd and Teva Pharms Usa and is included in three NDAs. It is available from three suppliers. Additional details are available on the EPTIFIBATIDE profile page.

The generic ingredient in EPTIFIBATIDE is eptifibatide. There are thirteen drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the eptifibatide profile page.

Summary for NDA: 206127

Aurobindo Pharma Ltd

Pharmacology for NDA: 206127

Physiological EffectDecreased Platelet Aggregation

Suppliers and Packaging for NDA: 206127

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INJECTABLE;INJECTION 206127 ANDA AuroMedics Pharma LLC 55150-218 55150-218-99 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-218-99) > 100 mL in 1 VIAL, SINGLE-DOSE
INJECTABLE;INJECTION 206127 ANDA AuroMedics Pharma LLC 55150-219 55150-219-10 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-219-10) > 10 mL in 1 VIAL, SINGLE-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength2MG/ML
Approval Date:Dec 8, 2015TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength75MG/100ML
Approval Date:Dec 8, 2015TE:APRLD: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.