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Approved Drug Products containing Leuprolide listed in the FDA Orange Book. Original Data : FDA Website

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

RLD : No

TE Code :

LEUPROLIDE ACETATE

Brand Name : LEUPROLIDE ACETATE

Dosage Form : SOLUTION;SUBCUTANEOUS

Dosage Strength : 14MG/2.8ML (1MG/0.2ML)

Approval Date : 2001-11-29

Application Number : 75721

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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02

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Not Confirmed

LEUPROLIDE ACETATE

Brand Name : LUPRON

Dosage Form : SOLUTION;SUBCUTANEOUS

Dosage Strength : 14MG/2.8ML (1MG/0.2ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1985-04-09

Application Number : 19010

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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03

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Luxepack
Not Confirmed

LEUPROLIDE ACETATE

Brand Name : LUPRON DEPOT

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 7.5MG

Approval Date : 1989-01-26

Application Number : 19732

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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05

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Luxepack
Not Confirmed

LEUPROLIDE ACETATE

Brand Name : LUPRON DEPOT

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 3.75MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1990-10-22

Application Number : 20011

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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06

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Luxepack
Not Confirmed

LEUPROLIDE ACETATE

Brand Name : LUPRON DEPOT

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 3.75MG

Approval Date : 1995-10-26

Application Number : 20011

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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07

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Luxepack
Not Confirmed

LEUPROLIDE ACETATE

Brand Name : LUPRON DEPOT-PED KIT

Dosage Form : POWDER;INTRAMUSCULAR

Dosage Strength : 7.5MG

Approval Date : 1993-04-16

Application Number : 20263

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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08

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Luxepack
Not Confirmed

LEUPROLIDE ACETATE

Brand Name : LUPRON DEPOT-PED KIT

Dosage Form : POWDER;INTRAMUSCULAR

Dosage Strength : 3.75MG,7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1993-04-16

Application Number : 20263

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Abbvie Company Banner

09

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Luxepack
Not Confirmed

LEUPROLIDE ACETATE

Brand Name : LUPRON DEPOT-PED KIT

Dosage Form : POWDER;INTRAMUSCULAR

Dosage Strength : 7.5MG,7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1993-04-16

Application Number : 20263

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Abbvie Company Banner

10

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Luxepack
Not Confirmed

LEUPROLIDE ACETATE

Brand Name : LUPRON DEPOT-PED KIT

Dosage Form : POWDER;INTRAMUSCULAR

Dosage Strength : 11.25MG

Approval Date : 1994-01-21

Application Number : 20263

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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