Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065439
Company: FRESENIUS KABI USA
Company: FRESENIUS KABI USA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
AZTREONAM | AZTREONAM | 500MG/VIAL | INJECTABLE;INJECTION | Prescription | None | No | No |
AZTREONAM | AZTREONAM | 1GM/VIAL | INJECTABLE;INJECTION | Prescription | AP | No | No |
AZTREONAM | AZTREONAM | 2GM/VIAL | INJECTABLE;INJECTION | Prescription | AP | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
06/18/2010 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2010/065439Orig1s000.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/29/2021 | SUPPL-14 | Labeling-Patient Package Insert |
Label is not available on this site. |
||
11/29/2021 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
04/28/2015 | SUPPL-5 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
04/28/2015 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
AZTREONAM
INJECTABLE;INJECTION; 1GM/VIAL
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
AZACTAM | AZTREONAM | 1GM/VIAL | INJECTABLE;INJECTION | Prescription | Yes | AP | 050580 | BRISTOL MYERS SQUIBB |
AZTREONAM | AZTREONAM | 1GM/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065439 | FRESENIUS KABI USA |
AZTREONAM | AZTREONAM | 1GM/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 206517 | HOSPIRA |
INJECTABLE;INJECTION; 2GM/VIAL
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
AZACTAM | AZTREONAM | 2GM/VIAL | INJECTABLE;INJECTION | Prescription | Yes | AP | 050580 | BRISTOL MYERS SQUIBB |
AZTREONAM | AZTREONAM | 2GM/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065439 | FRESENIUS KABI USA |
AZTREONAM | AZTREONAM | 2GM/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 206517 | HOSPIRA |