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Details for New Drug Application (NDA): 020604

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NDA 020604 describes SEROSTIM LQ, which is a drug marketed by Emd Serono and is included in one NDA. It is available from one supplier. Additional details are available on the SEROSTIM LQ profile page.

The generic ingredient in SEROSTIM LQ is somatropin recombinant. There are four drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the somatropin recombinant profile page.

Summary for NDA: 020604

Tradename:
SEROSTIM
Applicant:
Emd Serono
Ingredient:
somatropin recombinant
Patents:1
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 020604

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SEROSTIM
somatropin recombinant
INJECTABLE;INJECTION 020604 NDA EMD Serono, Inc. 44087-0004 44087-0004-7 1 KIT in 1 CARTON (44087-0004-7) * 1 mL in 1 VIAL * 3.5 mL in 1 VIAL, GLASS
SEROSTIM
somatropin recombinant
INJECTABLE;INJECTION 020604 NDA EMD Serono, Inc. 44087-0005 44087-0005-7 1 KIT in 1 CARTON (44087-0005-7) * 1 mL in 1 VIAL * 1 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength6MG/VIAL
Approval Date:Aug 23, 1996TE:BXRLD:No
Patent:5,898,030Patent Expiration:Apr 27, 2016Product Flag?YSubstance Flag?Delist Request?

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength5MG/VIAL
Approval Date:Aug 23, 1996TE:BXRLD:No
Patent:5,898,030Patent Expiration:Apr 27, 2016Product Flag?YSubstance Flag?Delist Request?

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength4MG/VIAL
Approval Date:Jul 25, 1997TE:BXRLD:No
Patent:5,898,030Patent Expiration:Apr 27, 2016Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 020604

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Emd Serono
SEROSTIM
somatropin recombinant
INJECTABLE;INJECTION020604-003Jul 25, 19975,898,030► subscribe
Emd Serono
SEROSTIM
somatropin recombinant
INJECTABLE;INJECTION020604-004Sep 6, 20015,898,030► subscribe
Emd Serono
SEROSTIM
somatropin recombinant
INJECTABLE;INJECTION020604-001Aug 23, 19965,898,030► subscribe
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