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Details for New Drug Application (NDA): 021149

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NDA 021149 describes OVIDREL, 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 OVIDREL profile page.

The generic ingredient in OVIDREL is choriogonadotropin alfa. One supplier is listed for this compound. Additional details are available on the choriogonadotropin alfa profile page.

Summary for NDA: 021149

Emd Serono
choriogonadotropin alfa

Pharmacology for NDA: 021149


Suppliers and Packaging for NDA: 021149

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
choriogonadotropin alfa
INJECTABLE;INJECTION 021149 NDA EMD Serono, Inc. 44087-1150 44087-1150-1 1 SYRINGE, GLASS in 1 CARTON (44087-1150-1) > .5 mL in 1 SYRINGE, GLASS
choriogonadotropin alfa
INJECTABLE;SUBCUTANEOUS 021149 NDA EMD Serono, Inc. 44087-1150 44087-1150-1 1 SYRINGE, GLASS in 1 CARTON (44087-1150-1) > .5 mL in 1 SYRINGE, GLASS

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength0.25MG/VIAL
Approval Date:Sep 20, 2000TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrengthEQ 0.25MG /0.5ML
Approval Date:Oct 6, 2003TE:RLD:Yes
Patent:6,706,681Patent Expiration:Mar 16, 2021Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 021149

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Emd Serono
choriogonadotropin alfa
INJECTABLE;INJECTION021149-001Sep 20, 20005,767,251<disabled>
Emd Serono
choriogonadotropin alfa
INJECTABLE;SUBCUTANEOUS021149-002Oct 6, 20035,767,251<disabled>
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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.