You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: November 24, 2024

Details for New Drug Application (NDA): 017078


✉ Email this page to a colleague

« Back to Dashboard


NDA 017078 describes DEXEDRINE SPANSULE, which is a drug marketed by Impax Labs Inc and is included in one NDA. It is available from two suppliers. Additional details are available on the DEXEDRINE SPANSULE profile page.

The generic ingredient in DEXEDRINE SPANSULE is dextroamphetamine sulfate. There are eighteen drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the dextroamphetamine sulfate profile page.
Summary for 017078
Tradename:DEXEDRINE SPANSULE
Applicant:Impax Labs Inc
Ingredient:dextroamphetamine sulfate
Patents:0
Pharmacology for NDA: 017078
Medical Subject Heading (MeSH) Categories for 017078
Suppliers and Packaging for NDA: 017078
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEXEDRINE SPANSULE dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 017078 NDA AUTHORIZED GENERIC Amneal Pharmaceuticals of New York LLC 0115-9927 0115-9927-10 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-9927-10)
DEXEDRINE SPANSULE dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 017078 NDA AUTHORIZED GENERIC Amneal Pharmaceuticals of New York LLC 0115-9928 0115-9928-10 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-9928-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength5MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength10MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength15MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

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 verification 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.