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.
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 |
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: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | 0.005MG/VIAL | ||||
| Approval Date: | Nov 22, 2022 | TE: | AP | RLD: | Yes | ||||
| Patent: | 11,110,063 | Patent Expiration: | Apr 20, 2038 | Product Flag? | Y | Substance 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: | 11,110,063 | Patent Expiration: | Apr 20, 2038 | Product Flag? | Y | Substance 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: | 11,110,063 | Patent Expiration: | Apr 20, 2038 | Product Flag? | Y | Substance 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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