Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021332
Company: ASTRAZENECA AB
Company: ASTRAZENECA AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SYMLIN | PRAMLINTIDE ACETATE | EQ 3MG BASE/5ML (EQ 600MCG BASE/ML) | INJECTABLE;SUBCUTANEOUS | Discontinued | None | No | No |
| SYMLIN | PRAMLINTIDE ACETATE | EQ 1.5MG BASE/1.5ML (EQ 1MG BASE/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | None | Yes | No |
| SYMLIN | PRAMLINTIDE ACETATE | EQ 2.7MG BASE/2.7ML (EQ 1MG BASE/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | None | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/18/2019 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021332s028lbl.pdf | |
| 03/20/2015 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021332s025lbl.pdf | |
| 02/25/2015 | SUPPL-23 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021332s023lbl.pdf | |
| 06/27/2014 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021332s007_S016.pdf | |
| 06/27/2014 | SUPPL-7 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021332s007_S016.pdf | |
| 09/25/2007 | SUPPL-6 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021332s006lbl.pdf | |
| 09/25/2007 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021332s006lbl.pdf | |
| 03/16/2005 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021332lbl.pdf |