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Details for New Drug Application (NDA): 019764

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NDA 019764 describes SAIZEN, which is a drug marketed by Emd Serono and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the SAIZEN profile page.

The generic ingredient in SAIZEN 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: 019764

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

Suppliers and Packaging for NDA: 019764

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SAIZEN
somatropin recombinant
INJECTABLE;INJECTION 019764 NDA EMD Serono, Inc. 44087-1005 44087-1005-2 1 KIT in 1 CARTON (44087-1005-2) * 3 mL in 1 VIAL, GLASS * 3.5 mL in 1 VIAL, GLASS
SAIZEN
somatropin recombinant
INJECTABLE;INJECTION 019764 NDA EMD Serono, Inc. 44087-1080 44087-1080-1 1 KIT in 1 CARTON (44087-1080-1) * 1.51 mL in 1 VIAL, GLASS * 1.51 mL in 1 CARTRIDGE

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength6MG/VIAL
Approval Date:Oct 8, 1996TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength5MG/VIAL
Approval Date:Oct 8, 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;INJECTIONStrength8.8MG/VIAL
Approval Date:Aug 29, 2000TE:RLD:Yes
Patent:5,898,030Patent Expiration:Apr 27, 2016Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 019764

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Emd Serono
SAIZEN
somatropin recombinant
INJECTABLE;INJECTION019764-002Oct 8, 19965,898,030► subscribe
Emd Serono
SAIZEN
somatropin recombinant
INJECTABLE;INJECTION019764-003Aug 29, 20005,898,030► 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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