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)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 003106627 | Symlin | NDA | Astrazeneca Pharmaceuticals Lp | 2015-01-08 | PRAMLINTIDE ACETATE | SUBCUTANEOUS | INJECTION | NDA021332 | 4aea30ff-eb0d-45c1-b114-3127966328ff |
1.5 ml pramlintide acetate 1 mg/ml pen injector
original product(s)(s)
| # | id | brand | category | labeler | first marketed | last marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 667800115 | Symlin | NDA | Amylin Pharmaceuticals, Llc | 2005-03-16 | 2016-08-31 | PRAMLINTIDE ACETATE | SUBCUTANEOUS | INJECTION | NDA021332 | d2262f20-bedb-43d9-b274-6ce275b0a69e |
application(s)
| # | id | title | applicant | approved | patent | approved drug |
|---|---|---|---|---|---|---|
| 1 | NDA021332 | SYMLIN | ASTRAZENECA AB | 2005-03-16 | p5814600, 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)
| # | id | category/deprecated | ingredient strength(s) | route | dose form | rld | approved | application |
|---|---|---|---|---|---|---|---|---|
| 1 | NDA021332_001 | discontinued | PRAMLINTIDE ACETATE (EQ 3MG BASE/5ML) | SUBCUTANEOUS | INJECTION | False | 2005-03-16 | SYMLIN |
| 2 | NDA021332_002 | RX | PRAMLINTIDE ACETATE (EQ 1.5MG BASE/1.5ML) | SUBCUTANEOUS | INJECTION | False | 2007-09-25 | SYMLIN |
| 3 | NDA021332_003 | RX | PRAMLINTIDE ACETATE (EQ 2.7MG BASE/2.7ML) | SUBCUTANEOUS | INJECTION | True | 2007-09-25 | SYMLIN |
patent(s)
| # | id | expiration date | application(s) |
|---|---|---|---|
| 1 | p5686411 (view patent) | 2019-03-16 | NDA021332 |
| 2 | p5814600 (view patent) | 2015-09-29 | NDA021332 |
| 3 | p6114304 (view patent) | 2017-09-05 | NDA021332 |
spl(s)
| # | id | title | category | type | labeler | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|
| 1 | 4aea30ff-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: 2005 | prescription | Human Prescription | Astrazeneca Pharmaceuticals Lp | 2015-03-20 | 3 | 003106627, 003106615 |
| 2 | d2262f20-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: 2005 | prescription | Human Prescription | Amylin Pharmaceuticals, Llc | 2014-08-14 | 11 | 667800115, 667800121 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII