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Generated: November 16, 2018

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Details for New Drug Application (NDA): 013718

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NDA 013718 describes OXANDRIN, which is a drug marketed by Gemini Labs Llc and is included in one NDA. Additional details are available on the OXANDRIN profile page.

The generic ingredient in OXANDRIN is oxandrolone. There are ten drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the oxandrolone profile page.
Summary for 013718
Tradename:OXANDRIN
Applicant:Gemini Labs Llc
Ingredient:oxandrolone
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 013718

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength2.5MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength10MG
Approval Date:Nov 5, 2001TE:RLD:Yes

Expired US Patents for NDA 013718

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gemini Labs Llc OXANDRIN oxandrolone TABLET;ORAL 013718-002 Nov 5, 2001 ➤ Sign Up ➤ Sign Up
Gemini Labs Llc OXANDRIN oxandrolone TABLET;ORAL 013718-001 Approved Prior to Jan 1, 1982 ➤ Sign Up ➤ Sign Up
Gemini Labs Llc OXANDRIN oxandrolone TABLET;ORAL 013718-001 Approved Prior to Jan 1, 1982 ➤ Sign Up ➤ Sign Up
Gemini Labs Llc OXANDRIN oxandrolone TABLET;ORAL 013718-002 Nov 5, 2001 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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