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Generated: August 20, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 089567

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NDA 089567 describes ORTHO-EST, which is a drug marketed by Sun Pharm Inds Inc and is included in two NDAs. Additional details are available on the ORTHO-EST profile page.

The generic ingredient in ORTHO-EST is estropipate. There are two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the estropipate profile page.

Summary for NDA: 089567

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength0.75MG
Approval Date:Feb 27, 1991TE:RLD:No


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US Department of Justice

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