Documents
Application Sponsors
Marketing Status
| Discontinued | 001 |
| Prescription | 002 |
| Prescription | 003 |
Application Products
| 001 | INJECTABLE;SUBCUTANEOUS | EQ 3MG BASE/5ML (EQ 600MCG BASE/ML) | 0 | SYMLIN | PRAMLINTIDE ACETATE |
| 002 | INJECTABLE;SUBCUTANEOUS | EQ 1.5MG BASE/1.5ML (EQ 1MG BASE/ML) | 1 | SYMLIN | PRAMLINTIDE ACETATE |
| 003 | INJECTABLE;SUBCUTANEOUS | EQ 2.7MG BASE/2.7ML (EQ 1MG BASE/ML) | 1 | SYMLIN | PRAMLINTIDE ACETATE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2005-03-16 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 2007-09-25 | N/A |
| EFFICACY; Efficacy | SUPPL | 7 | AP | 2014-06-27 | UNKNOWN |
| LABELING; Labeling | SUPPL | 10 | AP | 2008-08-04 | STANDARD |
| LABELING; Labeling | SUPPL | 16 | AP | 2014-06-27 | STANDARD |
| LABELING; Labeling | SUPPL | 20 | AP | 2012-01-03 | STANDARD |
| LABELING; Labeling | SUPPL | 23 | AP | 2015-02-25 | 901 REQUIRED |
| REMS; REMS | SUPPL | 24 | AP | 2015-08-07 | N/A |
| LABELING; Labeling | SUPPL | 25 | AP | 2015-03-20 | STANDARD |
| REMS; REMS | SUPPL | 26 | AP | 2017-03-08 | N/A |
| LABELING; Labeling | SUPPL | 28 | AP | 2019-12-18 | STANDARD |
Submissions Property Types
| SUPPL | 7 | Null | 7 |
| SUPPL | 16 | Null | 6 |
| SUPPL | 20 | Null | 7 |
| SUPPL | 23 | Null | 6 |
| SUPPL | 24 | Null | 6 |
| SUPPL | 25 | Null | 6 |
| SUPPL | 26 | Null | 7 |
| SUPPL | 28 | Null | 7 |
CDER Filings
ASTRAZENECA AB
cder:Array
(
[0] => Array
(
[ApplNo] => 21332
[companyName] => ASTRAZENECA AB
[docInserts] => ["Medication Guide","http:\/\/www.fda.gov\/downloads\/Drugs\/DrugSafety\/ucm089141.pdf"]
[products] => [{"drugName":"SYMLIN","activeIngredients":"PRAMLINTIDE ACETATE","strength":"EQ 3MG BASE\/5ML (EQ 600MCG BASE\/ML)","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"SYMLIN","activeIngredients":"PRAMLINTIDE ACETATE","strength":"EQ 1.5MG BASE\/1.5ML (EQ 1MG BASE\/ML)","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"SYMLIN","activeIngredients":"PRAMLINTIDE ACETATE","strength":"EQ 2.7MG BASE\/2.7ML (EQ 1MG BASE\/ML)","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"12\/18\/2019","submission":"SUPPL-28","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021332s028lbl.pdf\"}]","notes":""},{"actionDate":"03\/20\/2015","submission":"SUPPL-25","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021332s025lbl.pdf\"}]","notes":""},{"actionDate":"02\/25\/2015","submission":"SUPPL-23","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021332s023lbl.pdf\"}]","notes":""},{"actionDate":"06\/27\/2014","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021332s007_S016.pdf\"}]","notes":""},{"actionDate":"06\/27\/2014","submission":"SUPPL-7","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021332s007_S016.pdf\"}]","notes":""},{"actionDate":"09\/25\/2007","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021332s006lbl.pdf\"}]","notes":""},{"actionDate":"09\/25\/2007","submission":"SUPPL-6","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021332s006lbl.pdf\"}]","notes":""},{"actionDate":"03\/16\/2005","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021332lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"SYMLIN","submission":"PRAMLINTIDE ACETATE","actionType":"EQ 3MG BASE\/5ML (EQ 600MCG BASE\/ML)","submissionClassification":"INJECTABLE;SUBCUTANEOUS","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"SYMLIN","submission":"PRAMLINTIDE ACETATE","actionType":"EQ 1.5MG BASE\/1.5ML (EQ 1MG BASE\/ML)","submissionClassification":"INJECTABLE;SUBCUTANEOUS","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"SYMLIN","submission":"PRAMLINTIDE ACETATE","actionType":"EQ 2.7MG BASE\/2.7ML (EQ 1MG BASE\/ML)","submissionClassification":"INJECTABLE;SUBCUTANEOUS","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2019-12-18
)
)