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Generated: December 14, 2018

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Details for New Drug Application (NDA): 091234

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NDA 091234 describes DESOGESTREL AND ETHINYL ESTRADIOL, which is a drug marketed by Duramed Pharms Barr, Accord Hlthcare, Aurobindo Pharma Ltd, Mayne Pharma, Mylan Labs Ltd, Novast Labs, and Watson Labs, and is included in ten NDAs. It is available from six suppliers. Additional details are available on the DESOGESTREL AND ETHINYL ESTRADIOL profile page.

The generic ingredient in DESOGESTREL AND ETHINYL ESTRADIOL is desogestrel; ethinyl estradiol. There are eight drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the desogestrel; ethinyl estradiol profile page.
Summary for 091234
Suppliers and Packaging for NDA: 091234
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DESOGESTREL AND ETHINYL ESTRADIOL desogestrel; ethinyl estradiol TABLET;ORAL-28 091234 ANDA Northstar Rx LLC 16714-464 16714-464-01 1 BLISTER PACK in 1 PACKET (16714-464-01) > 1 KIT in 1 BLISTER PACK
DESOGESTREL AND ETHINYL ESTRADIOL desogestrel; ethinyl estradiol TABLET;ORAL-28 091234 ANDA Northstar Rx LLC 16714-464 16714-464-02 1 BLISTER PACK in 1 CARTON (16714-464-02) > 1 KIT in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength0.15MG;0.03MG
Approval Date:Jul 12, 2013TE:ABRLD:No

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