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Generated: July 21, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 017355

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NDA 017355 describes LOESTRIN FE 1.5/30, which is a drug marketed by Apil and is included in one NDA. It is available from two suppliers. Additional details are available on the LOESTRIN FE 1.5/30 profile page.

The generic ingredient in LOESTRIN FE 1.5/30 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: 017355

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

Suppliers and Packaging for NDA: 017355

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LOESTRIN FE 1.5/30
ethinyl estradiol; norethindrone acetate
TABLET;ORAL-28 017355 NDA AUTHORIZED GENERIC Mayne Pharma Inc. 51862-292 51862-292-06 6 BLISTER PACK in 1 CARTON (51862-292-06) > 1 KIT in 1 BLISTER PACK
LOESTRIN FE 1.5/30
ethinyl estradiol; norethindrone acetate
TABLET;ORAL-28 017355 NDA AUTHORIZED GENERIC Actavis Pharma, Inc. 52544-233 52544-233-28 6 BLISTER PACK in 1 CARTON (52544-233-28) > 1 KIT in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength0.03MG;1.5MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes


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Serving 500+ biopharmaceutical companies globally:

Fuji
McKesson
UBS
Medtronic
Express Scripts
Cipla
Dow
Merck
Teva
Cerilliant

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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