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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 210850


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NDA 210850 describes SINCALIDE, which is a drug marketed by Maia Pharms Inc and is included in one NDA. It is available from two suppliers. There are three patents protecting this drug. Additional details are available on the SINCALIDE profile page.

The generic ingredient in SINCALIDE is sincalide. There are three drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the sincalide profile page.
Summary for 210850
Tradename:SINCALIDE
Applicant:Maia Pharms Inc
Ingredient:sincalide
Patents:3
Pharmacology for NDA: 210850
Suppliers and Packaging for NDA: 210850
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SINCALIDE sincalide POWDER;INTRAVENOUS 210850 NDA MAIA Pharmaceuticals, Inc. 70511-131 70511-131-84 10 VIAL in 1 PACKAGE (70511-131-84) / 5 mL in 1 VIAL (70511-131-05)
SINCALIDE sincalide POWDER;INTRAVENOUS 210850 NDA FOSUN PHARMA USA INC 72266-248 72266-248-05 5 VIAL in 1 PACKAGE (72266-248-05) / 5 mL in 1 VIAL (72266-248-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INTRAVENOUSStrength0.005MG/VIAL
Approval Date:Nov 22, 2022TE:APRLD:Yes
Patent:⤷  Sign UpPatent Expiration:Apr 20, 2038Product Flag?YSubstance Flag?Delist Request?
Patented Use:DIAGNOSIS OF GALL BLADDER DISORDERS OR OTHER DIAGNOSTIC IMAGING BY STIMULATING GALLBLADDER CONTRACTION, AS MAY BE ASSESSED BY VARIOUS METHODS OF DIAGNOSTIC IMAGING, OR TO OBTAIN BY DUODENAL ASPIRATION A SAMPLE OF CONCENTRATED BILE FOR ANALYSIS
Patent:⤷  Sign UpPatent Expiration:Apr 20, 2038Product Flag?YSubstance Flag?Delist Request?
Patented Use:DIAGNOSIS OF PANCREATIC DISORDERS BY STIMULATING PANCREATIC SECRETION IN COMBINATION WITH SECRETIN PRIOR TO OBTAINING A DUODENAL ASPIRATE FOR ANALYSIS
Patent:⤷  Sign UpPatent Expiration:Apr 20, 2038Product Flag?YSubstance Flag?Delist Request?
Patented Use:DIAGNOSTIC IMAGING BY ACCELERATING THE TRAN IT OFA BARIUM MEAL THROUGH THE SMALL BOWEL, THEREBY DECREASING THE TIME AND EXTENT OF RADIATION ASSOCIATED WITH FLUOROSCOPY AND X-RAY EXAMINATION OF THE INTESTINAL TRACT

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