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Last Updated: November 20, 2019

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Details for New Drug Application (NDA): 021211

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NDA 021211 describes FOLLISTIM AQ, which is a drug marketed by Organon Usa Inc and is included in two NDAs. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the FOLLISTIM AQ profile page.

The generic ingredient in FOLLISTIM AQ is follitropin alfa/beta. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the follitropin alfa/beta profile page.
Summary for 021211
Tradename:FOLLISTIM AQ
Applicant:Organon Usa Inc
Ingredient:follitropin alfa/beta
Patents:2
Formulation / Manufacturing:see details
Pharmacology for NDA: 021211
Suppliers and Packaging for NDA: 021211
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FOLLISTIM AQ follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 021211 NDA Organon USA Inc. 0052-0313 0052-0313-01 1 KIT in 1 CARTON (0052-0313-01) > 1 CARTRIDGE in 1 KIT > .42 mL in 1 CARTRIDGE
FOLLISTIM AQ follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 021211 NDA Organon USA Inc. 0052-0313 0052-0313-81 1 KIT in 1 CARTON (0052-0313-81) > 1 CARTRIDGE in 1 KIT > .42 mL in 1 CARTRIDGE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrength300 IU/0.36ML
Approval Date:Mar 23, 2004TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Aug 23, 2019Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Aug 23, 2019Product Flag?Substance Flag?Delist Request?
Patented Use:A METHOD FOR ADMINISTERING FOLLICLE STIMULATING HORMONE (FSH) FOR OVARIAN FOLLICLE OR TESTICULAR STIMULATION IN THE HUMAN
Patent:  Start TrialPatent Expiration:Aug 23, 2019Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF ADMINISTERING FSH FOR THE TREATMENT OF INFERTILITY THROUGH INDUCTION OF OVULATION AND PREGNANCY IN ANOVULATORY INFERTILE WOMEN

Expired US Patents for NDA 021211

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Organon Usa Inc FOLLISTIM AQ follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 021211-002 Mar 23, 2004   Start Trial   Start Trial
Organon Usa Inc FOLLISTIM AQ follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 021211-003 Feb 11, 2004   Start Trial   Start Trial
Organon Usa Inc FOLLISTIM AQ follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 021211-004 Feb 11, 2005   Start Trial   Start Trial
Organon Usa Inc FOLLISTIM AQ follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 021211-001 Mar 23, 2004   Start Trial   Start Trial
Organon Usa Inc FOLLISTIM AQ follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 021211-003 Feb 11, 2004   Start Trial   Start Trial
Organon Usa Inc FOLLISTIM AQ follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 021211-001 Mar 23, 2004   Start Trial   Start Trial
Organon Usa Inc FOLLISTIM AQ follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 021211-001 Mar 23, 2004   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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