Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018893
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SODIUM ACETATE SODIUM ACETATE 2MEQ/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
05/04/1983 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
06/12/2014 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

09/02/2014 SUPPL-25 Manufacturing (CMC) Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018893s025lbl.pdf
03/03/2003 SUPPL-17 Manufacturing (CMC)-Control Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18893scs017ltr.pdf
02/16/2001 SUPPL-16 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/31/1999 SUPPL-15 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/22/1999 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

06/15/2000 SUPPL-13 Labeling

Label is not available on this site.

05/05/1998 SUPPL-12 Labeling

Label is not available on this site.

08/29/1996 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

01/17/1997 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

11/17/1988 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

12/11/1987 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

07/24/1986 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

05/14/1985 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

10/22/1984 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

03/15/1985 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

01/17/1984 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/02/2014 SUPPL-25 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018893s025lbl.pdf

SODIUM ACETATE

INJECTABLE;INJECTION; 2MEQ/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
SODIUM ACETATE SODIUM ACETATE 2MEQ/ML INJECTABLE;INJECTION Prescription Yes AP 018893 HOSPIRA
SODIUM ACETATE SODIUM ACETATE 2MEQ/ML INJECTABLE;INJECTION Prescription No AP 214805 MILLA PHARMS

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