Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018801
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
STERILE WATER FOR INJECTION STERILE WATER FOR INJECTION 100% (1ML) LIQUID;N/A Discontinued None Yes No
STERILE WATER FOR INJECTION STERILE WATER FOR INJECTION 100% (10ML) LIQUID;N/A Prescription AP Yes Yes
STERILE WATER FOR INJECTION STERILE WATER FOR INJECTION 100% (20ML) LIQUID;N/A Prescription None Yes Yes
STERILE WATER FOR INJECTION STERILE WATER FOR INJECTION 100% (50ML) LIQUID;N/A Prescription None Yes Yes
STERILE WATER FOR INJECTION STERILE WATER FOR INJECTION 100% (100ML) LIQUID;N/A Prescription None 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
10/27/1982 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
12/21/2016 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

03/29/2016 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

06/12/2014 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

08/01/2014 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

07/02/2009 SUPPL-34 Manufacturing (CMC)-Control Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018801s034ltr.pdf
04/07/2004 SUPPL-23 Manufacturing (CMC)-Control Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18801scs023ltr.pdf
02/16/2001 SUPPL-20 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/04/2000 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

06/16/2000 SUPPL-18 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/28/1999 SUPPL-17 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/27/1999 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

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

Label is not available on this site.

08/14/1998 SUPPL-14 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/13/1998 SUPPL-13 Labeling

Label is not available on this site.

08/29/1996 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

01/17/1997 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

04/17/1996 SUPPL-10 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

06/14/1989 SUPPL-8 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

10/21/1988 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

08/07/1985 SUPPL-6 Manufacturing (CMC)-Packaging

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.

06/14/1984 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/25/1984 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

STERILE WATER FOR INJECTION

LIQUID;N/A; 100% (10ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
STERILE WATER FOR INJECTION STERILE WATER FOR INJECTION 100% (10ML) LIQUID;N/A Prescription Yes AP 018801 HOSPIRA
STERILE WATER FOR INJECTION STERILE WATER FOR INJECTION 100% (10ML) LIQUID;N/A Prescription No AP 211188 MEDEFIL INC
STERILE WATER FOR INJECTION STERILE WATER FOR INJECTION 100% (10ML) LIQUID;N/A Prescription No AP 206369 WEST-WARD PHARMS INT

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