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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018892
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, MONOHYDRATE 4.02GM/15ML;4.14GM/15ML (268MG/ML;276MG/ML) SOLUTION;INTRAVENOUS 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

SOLUTION;INTRAVENOUS; 4.02GM/15ML;4.14GM/15ML (268MG/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, MONOHYDRATE 4.02GM/15ML;4.14GM/15ML (268MG/ML;276MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 218314 AM REGENT
SODIUM PHOSPHATES SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 4.02GM/15ML;4.14GM/15ML (268MG/ML;276MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 209997 FRESENIUS KABI USA
SODIUM PHOSPHATES IN PLASTIC CONTAINER SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 4.02GM/15ML;4.14GM/15ML (268MG/ML;276MG/ML) SOLUTION;INTRAVENOUS Prescription Yes AP 018892 HOSPIRA
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