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Application 050814
- Type
- NDA
- Sponsor
- GILEAD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | CAYSTON | AZTREONAM | FOR SOLUTION;INHALATION | 75MG/VIAL | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 61958-0901 | Cayston | aztreonam | Gilead Sciences, Inc. | NDA | Current |
| 61958-0901 | Cayston | aztreonam | Gilead Sciences, Inc. | NDA | Current |
| 61958-0901 | Cayston | aztreonam | Gilead Sciences, Inc. | NDA | Current |
| 61958-0901 | Cayston | aztreonam | Gilead Sciences, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 61012 | SUPPL | 2019-11-21 |
| 61007 | SUPPL | 2019-11-21 |
| 57610 | SUPPL | 2019-02-14 |
| 57504 | SUPPL | 2019-02-12 |
| 8336 | SUPPL | 2015-12-30 |
| 30604 | SUPPL | 2012-09-26 |
| 39382 | SUPPL | 2012-09-25 |
| 22251 | SUPPL | 2011-12-09 |
| 44788 | ORIG | 2011-03-04 |
| 22250 | ORIG | 2011-03-04 |
| 8335 | SUPPL | 2010-08-25 |
| 39381 | ORIG | 2010-03-03 |
| 30603 | ORIG | 2010-02-26 |