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Details for New Drug Application (NDA): 207304

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NDA 207304 describes INCASSIA, which is a drug marketed by Aurobindo Pharma Ltd and is included in one NDA. It is available from one supplier. Additional details are available on the INCASSIA profile page.

The generic ingredient in INCASSIA is norethindrone. There are twenty-six drug master file entries for this compound. Nineteen suppliers are listed for this compound. There are three tentative approvals for this compound. Additional details are available on the norethindrone profile page.

Summary for NDA: 207304

Tradename:
INCASSIA
Applicant:
Aurobindo Pharma Ltd
Ingredient:
norethindrone
Patents:0
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details

Pharmacology for NDA: 207304

Ingredient-typeProgesterone Congeners

Suppliers and Packaging for NDA: 207304

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INCASSIA
norethindrone
TABLET;ORAL-28 207304 ANDA Aurobindo Pharma Limited 65862-925 65862-925-28 1 BLISTER PACK in 1 CARTON (65862-925-28) > 1 TABLET in 1 BLISTER PACK
INCASSIA
norethindrone
TABLET;ORAL-28 207304 ANDA Aurobindo Pharma Limited 65862-925 65862-925-85 3 BLISTER PACK in 1 CARTON (65862-925-85) > 1 TABLET in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength0.35MG
Approval Date:Sep 23, 2016TE:AB1RLD: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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