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Details for New Drug Application (NDA): 021273

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NDA 021273 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: 021273

Tradename:
FOLLISTIM AQ
Applicant:
Organon Usa Inc
Ingredient:
follitropin alfa/beta
Patents:1
Formulation / Manufacturing:see details

Pharmacology for NDA: 021273

Ingredient-typeGonadotropins

Suppliers and Packaging for NDA: 021273

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FOLLISTIM AQ
follitropin alfa/beta
INJECTABLE;SUBCUTANEOUS 021273 NDA Organon USA Inc. 0052-0308 0052-0308-02 1 VIAL, SINGLE-USE in 1 CARTON (0052-0308-02) > .5 mL in 1 VIAL, SINGLE-USE
FOLLISTIM AQ
follitropin alfa/beta
INJECTABLE;SUBCUTANEOUS 021273 NDA Organon USA Inc. 0052-0308 0052-0308-82 1 VIAL, SINGLE-USE in 1 CARTON (0052-0308-82) > .5 mL in 1 VIAL, SINGLE-USE

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;SUBCUTANEOUSStrength75 IU/0.5ML
Approval Date:Aug 26, 2005TE:RLD:No
Patent:5,929,028Patent Expiration:Jan 14, 2018Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF INFERTILITY THROUGH INDUCTION OF OVULATION AND PREGNANCY TO ANOVULATORY INFERTILE WOMEN

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;SUBCUTANEOUSStrength150 IU/0.5ML
Approval Date:Aug 26, 2005TE:RLD:No
Patent:5,929,028Patent Expiration:Jan 14, 2018Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF INFERTILITY THROUGH INDUCTION OF OVULATION AND PREGNANCY TO ANOVULATORY INFERTILE WOMEN

Expired Orange Book Patents for NDA: 021273

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Organon Usa Inc
FOLLISTIM AQ
follitropin alfa/beta
INJECTABLE;SUBCUTANEOUS021273-001Aug 26, 20055,767,251► subscribe
Organon Usa Inc
FOLLISTIM AQ
follitropin alfa/beta
INJECTABLE;SUBCUTANEOUS021273-002Aug 26, 20055,767,251► subscribe
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