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Details for New Drug Application (NDA): 075256

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NDA 075256 describes DESOGESTREL AND ETHINYL ESTRADIOL, which is a drug marketed by Watson Labs, Mayne Pharma, Novast Labs Ltd, Duramed Pharms Barr, and Mylan Labs Ltd, and is included in seven NDAs. It is available from ten 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. Twenty suppliers are listed for this compound. Additional details are available on the desogestrel; ethinyl estradiol profile page.

Summary for NDA: 075256

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 075256

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DESOGESTREL AND ETHINYL ESTRADIOL
desogestrel; ethinyl estradiol
TABLET;ORAL-21 075256 ANDA Teva Pharmaceuticals USA, Inc. 0093-3304 0093-3304-16 6 POUCH in 1 CARTON (0093-3304-16) > 1 BLISTER PACK in 1 POUCH (0093-3304-28) > 1 KIT in 1 BLISTER PACK
DESOGESTREL AND ETHINYL ESTRADIOL
desogestrel; ethinyl estradiol
TABLET;ORAL-21 075256 ANDA Barr Laboratories Inc. 0555-9043 0555-9043-58 6 POUCH in 1 CARTON (0555-9043-58) > 1 BLISTER PACK in 1 POUCH > 1 KIT in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORAL-21Strength0.15MG;0.03MG
Approval Date:Aug 12, 1999TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength0.15MG;0.03MG
Approval Date:Aug 12, 1999TE:ABRLD: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.

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