Application 050632
- Type
- NDA
- Sponsor
- BRISTOL MYERS SQUIBB
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | AZACTAM IN PLASTIC CONTAINER | AZTREONAM | INJECTABLE;INJECTION | 40MG/ML | Yes | No |
| 002 | AZACTAM IN PLASTIC CONTAINER | AZTREONAM | INJECTABLE;INJECTION | 20MG/ML | Yes | No |
| 003 | AZACTAM IN PLASTIC CONTAINER | AZTREONAM | INJECTABLE;INJECTION | 10MG/ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0003-2230 | AZACTAM | AZTREONAM | E.R. Squibb & Sons, L.L.C. | NDA | Current |
| 0003-2240 | AZACTAM | AZTREONAM | E.R. Squibb & Sons, L.L.C. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 54676 | SUPPL | 2018-06-21 |
| 54637 | SUPPL | 2018-06-21 |
| 7912 | SUPPL | 2013-06-18 |
| 17956 | SUPPL | 2013-06-17 |
| 39057 | SUPPL | 2008-01-24 |
| 7911 | SUPPL | 2008-01-24 |
| 30196 | SUPPL | 2004-12-30 |
| 30195 | SUPPL | 2002-03-25 |
| 39056 | SUPPL | 1998-12-24 |
| 22172 | SUPPL | 1998-12-24 |
| 7910 | SUPPL | 1998-12-24 |