Application 021332
- Type
- NDA
- Sponsor
- ASTRAZENECA AB
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SYMLIN | PRAMLINTIDE ACETATE | INJECTABLE;SUBCUTANEOUS | EQ 3MG BASE/5ML (EQ 600MCG BASE/ML) | No | No |
| 002 | SYMLIN | PRAMLINTIDE ACETATE | INJECTABLE;SUBCUTANEOUS | EQ 1.5MG BASE/1.5ML (EQ 1MG BASE/ML) | Yes | No |
| 003 | SYMLIN | PRAMLINTIDE ACETATE | INJECTABLE;SUBCUTANEOUS | EQ 2.7MG BASE/2.7ML (EQ 1MG BASE/ML) | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0310-6615 | SymlinPen | pramlintide acetate | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-6615 | SymlinPen | pramlintide acetate | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-6615 | SymlinPen | pramlintide acetate | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-6627 | SymlinPen | pramlintide acetate | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-6627 | SymlinPen | pramlintide acetate | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-6627 | SymlinPen | pramlintide acetate | AstraZeneca Pharmaceuticals LP | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 61383 | SUPPL | 2019-12-23 |
| 61358 | SUPPL | 2019-12-19 |
| 47544 | SUPPL | 2017-03-14 |
| 27501 | SUPPL | 2015-08-11 |
| 27502 | SUPPL | 2015-04-13 |
| 36673 | SUPPL | 2015-03-24 |
| 15206 | SUPPL | 2015-03-03 |
| 5062 | SUPPL | 2015-02-27 |
| 36672 | SUPPL | 2014-07-01 |
| 15205 | SUPPL | 2014-07-01 |
| 27499 | SUPPL | 2014-06-30 |
| 5060 | SUPPL | 2014-06-30 |
| 27500 | SUPPL | 2012-01-05 |
| 5061 | SUPPL | 2008-08-06 |
| 27498 | SUPPL | 2007-10-04 |
| 36671 | SUPPL | 2007-09-26 |
| 23256 | ORIG | 2007-02-28 |
| 42103 | ORIG | 2005-06-14 |
| 36670 | ORIG | 2005-03-18 |
| 5059 | ORIG | 2005-03-18 |