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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 three 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 NDA: 021211

Tradename:
FOLLISTIM AQ
Applicant:
Organon Usa Inc
Ingredient:
follitropin alfa/beta
Patents:3
Formulation / Manufacturing:see details

Pharmacology for NDA: 021211

Ingredient-typeGonadotropins

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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrength300 IU/0.36ML
Approval Date:Mar 23, 2004TE:RLD:Yes
Patent:7,446,090Patent Expiration:Aug 23, 2019Product Flag?YSubstance Flag?Delist Request?
Patent:7,563,763Patent 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:7,563,763Patent 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 Orange Book Patents for NDA: 021211

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Organon Usa Inc
FOLLISTIM AQ
follitropin alfa/beta
INJECTABLE;SUBCUTANEOUS021211-004Feb 11, 20055,767,251► subscribe
Organon Usa Inc
FOLLISTIM AQ
follitropin alfa/beta
INJECTABLE;SUBCUTANEOUS021211-001Mar 23, 20044,589,402► subscribe
Organon Usa Inc
FOLLISTIM AQ
follitropin alfa/beta
INJECTABLE;SUBCUTANEOUS021211-001Mar 23, 20045,767,251► subscribe
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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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