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Last Updated: January 29, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 207580

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NDA 207580 describes AUROVELA FE 1.5/30, which is a drug marketed by Aurobindo Pharma Ltd and is included in one NDA. It is available from one supplier. Additional details are available on the AUROVELA FE 1.5/30 profile page.

The generic ingredient in AUROVELA FE 1.5/30 is ethinyl estradiol; norethindrone acetate. There are twenty-six drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.
Summary for 207580
Suppliers and Packaging for NDA: 207580
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AUROVELA FE 1.5/30 ethinyl estradiol; norethindrone acetate TABLET;ORAL-28 207580 ANDA Aurobindo Pharma Limited 65862-941 65862-941-58 5 POUCH in 1 CARTON (65862-941-58) > 1 BLISTER PACK in 1 POUCH (65862-941-87) > 1 KIT in 1 BLISTER PACK
AUROVELA FE 1.5/30 ethinyl estradiol; norethindrone acetate TABLET;ORAL-28 207580 ANDA Aurobindo Pharma Limited 65862-941 65862-941-88 3 POUCH in 1 CARTON (65862-941-88) > 1 BLISTER PACK in 1 POUCH > 1 KIT in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength0.03MG;1.5MG
Approval Date:Jun 15, 2017TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Medtronic
Johnson and Johnson
McKesson
Express Scripts
Merck
Moodys

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