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Details for New Drug Application (NDA): 020071

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NDA 020071 describes DESOGEN, which is a drug marketed by Organon Usa Inc and is included in one NDA. It is available from one supplier. Additional details are available on the DESOGEN profile page.

The generic ingredient in DESOGEN is desogestrel; ethinyl estradiol. There are eight drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the desogestrel; ethinyl estradiol profile page.

Summary for NDA: 020071

Tradename:
DESOGEN
Applicant:
Organon Usa Inc
Ingredient:
desogestrel; ethinyl estradiol
Patents:0
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 020071

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DESOGEN
desogestrel; ethinyl estradiol
TABLET;ORAL-21 020071 NDA Organon USA Inc. 0052-0261 0052-0261-06 6 BLISTER PACK in 1 BOX (0052-0261-06) > 1 KIT in 1 BLISTER PACK * 21 TABLET in 1 BLISTER PACK * 7 TABLET in 1 BLISTER PACK
DESOGEN
desogestrel; ethinyl estradiol
TABLET;ORAL-21 020071 NDA Organon USA Inc. 0052-0261 0052-0261-08 1 BLISTER PACK in 1 BOX (0052-0261-08) > 1 KIT in 1 BLISTER PACK * 21 TABLET in 1 BLISTER PACK * 7 TABLET in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORAL-21Strength0.15MG;0.03MG
Approval Date:Dec 10, 1992TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength0.15MG;0.03MG
Approval Date:Dec 10, 1992TE:ABRLD:No

Expired Orange Book Patents for NDA: 020071

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Organon Usa Inc
DESOGEN
desogestrel; ethinyl estradiol
TABLET;ORAL-21020071-001Dec 10, 19923,927,046► subscribe
Organon Usa Inc
DESOGEN
desogestrel; ethinyl estradiol
TABLET;ORAL-28020071-002Dec 10, 19923,927,046► subscribe
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