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Details for New Drug Application (NDA): 020130

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NDA 020130 describes ESTROSTEP FE, which is a drug marketed by Apil and is included in one NDA. It is available from four suppliers. Additional details are available on the ESTROSTEP FE profile page.

The generic ingredient in ESTROSTEP FE is ethinyl estradiol; norethindrone acetate. There are twenty-six drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.

Summary for NDA: 020130

Tradename:
2
Applicant:
1
Ingredient:
1
Patents:1
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 020130

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ESTROSTEP 21
ethinyl estradiol; norethindrone acetate
TABLET;ORAL-21 020130 NDA Warner Chilcott (US), LLC 0430-0005 0430-0005-31 72 CARTON in 1 CASE (0430-0005-31) > 3 CELLO PACK in 1 CARTON > 1 BLISTER PACK in 1 CELLO PACK > 1 KIT in 1 BLISTER PACK
ESTROSTEP 21
ethinyl estradiol; norethindrone acetate
TABLET;ORAL-21 020130 NDA Warner Chilcott (US), LLC 0430-0570 0430-0570-14 72 CARTON in 1 CASE (0430-0570-14) > 5 CELLO PACK in 1 CARTON > 1 BLISTER PACK in 1 CELLO PACK > 1 KIT in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORAL-21Strength0.02MG,0.03MG,0.035MG;1MG,1MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Oct 9, 1996TE:RLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength0.02MG,0.03MG,0.035MG;1MG,1MG,1MG
Approval Date:Oct 9, 1996TE:ABRLD:Yes

Expired Orange Book Patents for NDA: 020130

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Apil
ESTROSTEP 21
ethinyl estradiol; norethindrone acetate
TABLET;ORAL-21020130-001Oct 9, 19964,962,098► Subscribe
Apil
ESTROSTEP 21
ethinyl estradiol; norethindrone acetate
TABLET;ORAL-21020130-001Oct 9, 19965,010,070► Subscribe
Apil
ESTROSTEP FE
ethinyl estradiol; norethindrone acetate
TABLET;ORAL-28020130-002Oct 9, 19965,010,070► Subscribe
Apil
ESTROSTEP FE
ethinyl estradiol; norethindrone acetate
TABLET;ORAL-28020130-002Oct 9, 19964,962,098► Subscribe
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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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