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Details for New Drug Application (NDA): 201444

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NDA 201444 describes NITHIODOTE, which is a drug marketed by Hope Pharms 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 NITHIODOTE profile page.

The generic ingredient in NITHIODOTE is sodium nitrite; sodium thiosulfate. There are one thousand three hundred and thirty-six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the sodium nitrite; sodium thiosulfate profile page.

Summary for NDA: 201444

Hope Pharms
sodium nitrite; sodium thiosulfate
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 201444

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
sodium nitrite; sodium thiosulfate
SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS 201444 NDA Hope Pharmaceuticals 60267-812 60267-812-00 1 KIT in 1 CARTON (60267-812-00) * 10 mL in 1 VIAL, SINGLE-USE (60267-311-10) * 50 mL in 1 VIAL, SINGLE-USE (60267-705-50)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUSStrength300MG/10ML(30MG/ML),N/A;N/A,12.5GM/50ML(250MG/ML)
Approval Date:Jan 14, 2011TE:RLD:Yes
Patent:8,568,793Patent Expiration:Dec 24, 2031Product Flag?YSubstance Flag?YDelist Request?
Regulatory Exclusivity Expiration:Jan 14, 2018
Regulatory Exclusivity Use:ORPHAN DRUG EXCLUSIVITY
Patent:8,496,973Patent Expiration:Mar 29, 2031Product Flag?YSubstance Flag?YDelist Request?

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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.