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Details for New Drug Application (NDA): 021684

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NDA 021684 describes GONAL-F RFF REDI-JECT, which is a drug marketed by Emd Serono and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the GONAL-F RFF REDI-JECT profile page.

The generic ingredient in GONAL-F RFF REDI-JECT 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: 021684

Tradename:
GONAL-F RFF REDI-JECT
Applicant:
Emd Serono
Ingredient:
follitropin alfa/beta
Patents:2
Formulation / Manufacturing:see details

Pharmacology for NDA: 021684

Ingredient-typeGonadotropins

Suppliers and Packaging for NDA: 021684

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GONAL-F RFF REDI-JECT
follitropin alfa/beta
INJECTABLE;SUBCUTANEOUS 021684 NDA EMD Serono, Inc. 44087-1112 44087-1112-1 1 CARTRIDGE in 1 CARTON (44087-1112-1) > .75 mL in 1 CARTRIDGE
GONAL-F RFF REDI-JECT
follitropin alfa/beta
INJECTABLE;SUBCUTANEOUS 021684 NDA EMD Serono, Inc. 44087-1113 44087-1113-1 1 CARTRIDGE in 1 CARTON (44087-1113-1) > .5 mL in 1 CARTRIDGE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrength300 IU/0.5ML
Approval Date:May 25, 2004TE:RLD:Yes
Patent:7,446,090Patent Expiration:Aug 23, 2019Product Flag?YSubstance Flag?Delist Request?
Patent:7,741,268Patent Expiration:Apr 2, 2024Product Flag?YSubstance Flag?Delist Request?

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrength450 IU/0.75ML
Approval Date:May 25, 2004TE:RLD:Yes
Patent:7,446,090Patent Expiration:Aug 23, 2019Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 021684

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Emd Serono
GONAL-F RFF REDI-JECT
follitropin alfa/beta
INJECTABLE;SUBCUTANEOUS021684-001May 25, 20045,767,067► subscribe
Emd Serono
GONAL-F RFF REDI-JECT
follitropin alfa/beta
INJECTABLE;SUBCUTANEOUS021684-002May 25, 20045,767,067► subscribe
Emd Serono
GONAL-F RFF REDI-JECT
follitropin alfa/beta
INJECTABLE;SUBCUTANEOUS021684-003May 25, 20045,767,251► subscribe
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