SYMPROIC is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Biodelivery Sciences International Inc. The primary component is Naldemedine Tosylate.
Product ID | 59385-041_25f2969e-51fe-4cea-80ba-6be461a7b92f |
NDC | 59385-041 |
Product Type | Human Prescription Drug |
Proprietary Name | SYMPROIC |
Generic Name | Naldemedine Tosylate |
Dosage Form | Tablet |
Route of Administration | ORAL |
Marketing Start Date | 2019-06-14 |
Marketing Category | NDA / NDA |
Application Number | NDA208854 |
Labeler Name | BioDelivery Sciences International Inc |
Substance Name | NALDEMEDINE TOSYLATE |
Active Ingredient Strength | 0 mg/1 |
Pharm Classes | Opioid Antagonist [EPC],Opioid Antagonists [MoA] |
NDC Exclude Flag | N |
Listing Certified Through | 2020-12-31 |
Marketing Start Date | 2020-07-01 |
NDC Exclude Flag | N |
Sample Package? | N |
Marketing Category | NDA |
Application Number | NDA208854 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | EA |
Marketing Start Date | 2019-06-14 |
Marketing Category | NDA |
Application Number | NDA208854 |
Product Type | HUMAN PRESCRIPTION DRUG |
Marketing Start Date | 2020-01-01 |
Marketing End Date | 2019-12-03 |
Ingredient | Strength |
---|---|
NALDEMEDINE TOSYLATE | .2 mg/1 |
SPL SET ID: | b1a1256c-a1eb-4abe-ab1e-30e4711afd16 |
Manufacturer | |
UNII |
NDC | Brand Name | Generic Name |
---|---|---|
59011-523 | Symproic | naldemedine |
59385-041 | SYMPROIC | naldemedine tosylate |
59630-222 | SYMPROIC | naldemedine |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SYMPROIC 79168243 4887392 Live/Registered |
SHIONOGI & CO., LTD. 2015-01-27 |