Pramlintide Pen Injector

Brand(s)
Symlin
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Astrazeneca Pharmaceuticals Lp (2015-03-20)
Oldest Current Product
2005-03-16
License(s)
NDA
RxNORM
PEN INJECTOR\PRAMLINTIDE
FDAOB
SUBCUTANEOUS\INJECTION\PRAMLINTIDE ACETATE
SPL Active
SUBCUTANEOUS\INJECTION\PRAMLINTIDE ACETATE
SPL Moiety
SUBCUTANEOUS\INJECTION\PRAMLINTIDE

product(s) by strength(s)

2.7 ml pramlintide acetate 1 mg/ml pen injector

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003106627SymlinNDAAstrazeneca Pharmaceuticals Lp2015-01-08PRAMLINTIDE ACETATESUBCUTANEOUSINJECTIONNDA0213324aea30ff-eb0d-45c1-b114-3127966328ff

1.5 ml pramlintide acetate 1 mg/ml pen injector

original product(s)(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1667800115SymlinNDAAmylin Pharmaceuticals, Llc2005-03-162016-08-31PRAMLINTIDE ACETATESUBCUTANEOUSINJECTIONNDA021332d2262f20-bedb-43d9-b274-6ce275b0a69e

application(s)

#idtitleapplicantapprovedpatentapproved drug
1NDA021332SYMLINASTRAZENECA AB2005-03-16p5814600, TREATMENT OF DIABETES WITH AN AMYLIN AGONIST/ TREATMENT OF A MAMMAL HAVING A NEED OF OR REDUCED ABILITY TO PRODUCE INSULIN WITH AN INSULIN AND AN AMYLIN SUCH AS PRAMLINTIDE/ TREATMENT OF DIABETES WITH AN AMYLIN AGONIST
p6114304, USE OF AN AMYLIN AGONIST TO REDUCE GASTRIC MOTILITY AND TREAT POST PRANDIAL HYPERGYLCEMIA/ TREATMENT OF DIABETES WITH AN AMYLIN AGONIST
p5686411, TREATMENT OF DIABETES WITH AN AMYLIN AGONIST, SUBSTANCE
NDA021332_001, NDA021332_002, NDA021332_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA021332_001discontinuedPRAMLINTIDE ACETATE (EQ 3MG BASE/5ML)SUBCUTANEOUSINJECTIONFalse2005-03-16SYMLIN
2NDA021332_002RXPRAMLINTIDE ACETATE (EQ 1.5MG BASE/1.5ML)SUBCUTANEOUSINJECTIONFalse2007-09-25SYMLIN
3NDA021332_003RXPRAMLINTIDE ACETATE (EQ 2.7MG BASE/2.7ML)SUBCUTANEOUSINJECTIONTrue2007-09-25SYMLIN

patent(s)

#idexpiration dateapplication(s)
1p5686411 (view patent)2019-03-16NDA021332
2p5814600 (view patent)2015-09-29NDA021332
3p6114304 (view patent)2017-09-05NDA021332

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
14aea30ff-eb0d-45c1-b114-3127966328ff (view SPL)These highlights do not include all the information needed to use SYMLIN safely and effectively. See full prescribing information for SYMLIN. SYMLIN (pramlintide acetate) injection for subcutaneous useInitial U.S. Approval: 2005prescriptionHuman PrescriptionAstrazeneca Pharmaceuticals Lp2015-03-203003106627, 003106615
2d2262f20-bedb-43d9-b274-6ce275b0a69e (view SPL)These highlights do not include all the information needed to use SYMLIN safely and effectively. See full prescribing information for SYMLIN. SYMLIN (pramlintide acetate) injection for subcutaneous use Initial U.S. Approval: 2005prescriptionHuman PrescriptionAmylin Pharmaceuticals, Llc2014-08-1411667800115, 667800121

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII