Drugs@FDA: FDA-Approved Drugs
Company: HOSPIRA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SODIUM PHOSPHATES IN PLASTIC CONTAINER | SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS | 142MG/ML;276MG/ML | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
05/10/1983 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/30/2023 | SUPPL-38 | Manufacturing (CMC)-Packaging |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/018892Orig1s038.pdf |
07/17/2023 | SUPPL-37 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/018892Orig1s037.pdf |
01/12/2015 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/12/2014 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/14/2002 | SUPPL-21 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18892s21ltr.pdf |
02/16/2001 | SUPPL-20 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
08/31/1999 | SUPPL-19 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
06/16/2000 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
01/22/1999 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
11/19/1997 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
08/29/1996 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
01/17/1997 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
07/18/1989 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
10/21/1988 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
08/26/1987 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
12/11/1987 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
10/21/1986 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
07/24/1986 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
10/22/1984 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
03/15/1985 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
01/17/1984 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
10/24/1983 | SUPPL-2 | Labeling |
Label is not available on this site. |
SODIUM PHOSPHATES IN PLASTIC CONTAINER
INJECTABLE;INJECTION; 142MG/ML;276MG/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
SODIUM PHOSPHATES | SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS | 142MG/ML;276MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 218314 | AM REGENT |
SODIUM PHOSPHATES | SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS | 142MG/ML;276MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 209997 | FRESENIUS KABI USA |
SODIUM PHOSPHATES IN PLASTIC CONTAINER | SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS | 142MG/ML;276MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 018892 | HOSPIRA |