Approvals (Drugs@FDA)

BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER

HOSPIRA · STERILE WATER FOR INJECTION

NDA018802Drug (NDA)Prescription
Open FDA's page for this record
Application number
NDA018802
Sponsor name
HOSPIRA
Submissions
  1. Submission type
    SUPPL
    Submission number
    26
    Submission status
    AP
    Submission status date
    20150626
    Review priority
    STANDARD
    Submission class code
    MANUF (CMC)
    Submission class code description
    Manufacturing (CMC)
  2. Submission type
    SUPPL
    Submission number
    9
    Submission status
    AP
    Submission status date
    19960829
    Review priority
    STANDARD
    Submission class code
    MANUF (CMC)
    Submission class code description
    Manufacturing (CMC)
  3. Submission type
    SUPPL
    Submission number
    12
    Submission status
    AP
    Submission status date
    19990623
    Review priority
    STANDARD
    Submission class code
    MANUF (CMC)
    Submission class code description
    Manufacturing (CMC)
  4. Submission type
    SUPPL
    Submission number
    10
    Submission status
    AP
    Submission status date
    19971119
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
  5. Submission type
    SUPPL
    Submission number
    5
    Submission status
    AP
    Submission status date
    19841022
    Review priority
    STANDARD
    Submission class code
    MANUF (CMC)
    Submission class code description
    Manufacturing (CMC)
  6. Submission type
    SUPPL
    Submission number
    3
    Submission status
    AP
    Submission status date
    19840117
    Review priority
    STANDARD
    Submission class code
    MANUF (CMC)
    Submission class code description
    Manufacturing (CMC)
  7. Submission type
    SUPPL
    Submission number
    1
    Submission status
    AP
    Submission status date
    19840125
    Review priority
    STANDARD
    Submission class code
    MANUF (CMC)
    Submission class code description
    Manufacturing (CMC)
  8. Submission type
    SUPPL
    Submission number
    27
    Submission status
    AP
    Submission status date
    20161222
    Review priority
    STANDARD
    Submission class code
    MANUF (CMC)
    Submission class code description
    Manufacturing (CMC)
  9. Submission type
    SUPPL
    Submission number
    25
    Submission status
    AP
    Submission status date
    20140612
    Review priority
    STANDARD
    Submission class code
    MANUF (CMC)
    Submission class code description
    Manufacturing (CMC)
  10. Submission type
    SUPPL
    Submission number
    13
    Submission status
    AP
    Submission status date
    20000615
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
  11. Submission type
    SUPPL
    Submission number
    11
    Submission status
    AP
    Submission status date
    19970930
    Review priority
    STANDARD
    Submission class code
    MANUF (CMC)
    Submission class code description
    Manufacturing (CMC)
  12. Submission type
    SUPPL
    Submission number
    6
    Submission status
    AP
    Submission status date
    19881023
    Review priority
    STANDARD
    Submission class code
    MANUF (CMC)
    Submission class code description
    Manufacturing (CMC)
  13. +3 more not shown
Products
  1. Product number
    001
    Reference drug
    Yes
    Brand name
    BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER
    Reference standard
    Yes
    Dosage form
    LIQUID
    Route
    N/A
    Marketing status
    Prescription
    Te code
    AP
    Active ingredients
    1. Name
      STERILE WATER FOR INJECTION
      Strength
      100%
Harmonized identifiers (openFDA)
Application number
NDA018802
Brand name
BACTERIOSTATIC WATER
Generic name
BACTERIOSTATIC WATER
Manufacturer name
Hospira, Inc.
Product NDC
0409-3977, 0409-1093
Product type
HUMAN PRESCRIPTION DRUG
Route
INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Substance name
WATER
SPL ID
dfac2c43-36b4-4fc0-a22d-f70c4aad5f97
SPL set ID
87d6e9dc-fe3b-4593-ac9a-d7493d1959c7
Package NDC
0409-3977-01, 0409-3977-03, 0409-1093-14, 0409-1093-04
UNII
059QF0KO0R
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.