Approvals (Drugs@FDA)

OPTISON

GE HEALTHCARE · ALBUMIN HUMAN

NDA020899Drug (NDA)Prescription
Open FDA's page for this record
Application number
NDA020899
Sponsor name
GE HEALTHCARE
Submissions
  1. Submission type
    SUPPL
    Submission number
    23
    Submission status
    AP
    Submission status date
    20210901
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Application docs
    1. ID
      68533
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020899Orig1s023ltr.pdf
      Date
      20210903
      Type
      Letter
  2. Submission type
    SUPPL
    Submission number
    15
    Submission status
    AP
    Submission status date
    20120817
    Review priority
    STANDARD
    Submission class code
    EFFICACY
    Submission class code description
    Efficacy
    Application docs
    1. ID
      35600
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020899s015lbl.pdf
      Date
      20120820
      Type
      Label
    2. ID
      26144
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020899Orig1s015ltr.pdf
      Date
      20120820
      Type
      Letter
  3. Submission type
    SUPPL
    Submission number
    11
    Submission status
    AP
    Submission status date
    20080606
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Application docs
    1. ID
      3691
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020899s011ltr.pdf
      Date
      20080609
      Type
      Letter
    2. ID
      35599
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020899s011lbl.pdf
      Date
      20080612
      Type
      Label
  4. Submission type
    SUPPL
    Submission number
    6
    Submission status
    AP
    Submission status date
    20001218
    Review priority
    STANDARD
    Submission class code
    MANUF (CMC)
    Submission class code description
    Manufacturing (CMC)
  5. Submission type
    SUPPL
    Submission number
    4
    Submission status
    AP
    Submission status date
    20000204
    Review priority
    STANDARD
    Submission class code
    MANUF (CMC)
    Submission class code description
    Manufacturing (CMC)
  6. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    19971231
    Review priority
    STANDARD
    Submission class code
    TYPE 3
    Submission class code description
    Type 3 - New Dosage Form
    Application docs
    1. ID
      23609
      Url
      http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm110260.htm
      Date
      20080711
      Type
      Other Important Information from FDA
  7. Submission type
    SUPPL
    Submission number
    2
    Submission status
    AP
    Submission status date
    19990201
    Review priority
    STANDARD
    Submission class code
    MANUF (CMC)
    Submission class code description
    Manufacturing (CMC)
  8. Submission type
    SUPPL
    Submission number
    18
    Submission status
    AP
    Submission status date
    20160916
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Application docs
    1. ID
      45313
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020899s018s019lbl.pdf
      Date
      20160916
      Type
      Label
    2. ID
      45346
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020899Orig1s018,s019ltr.pdf
      Date
      20160920
      Type
      Letter
  9. Submission type
    SUPPL
    Submission number
    24
    Submission status
    AP
    Submission status date
    20210916
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Application docs
    1. ID
      68654
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020899Orig1s024ltr.pdf
      Date
      20210920
      Type
      Letter
    2. ID
      68668
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020899s024lbl.pdf
      Date
      20210920
      Type
      Label
  10. Submission type
    SUPPL
    Submission number
    16
    Submission status
    AP
    Submission status date
    20131115
    Review priority
    STANDARD
    Submission class code
    MANUF (CMC)
    Submission class code description
    Manufacturing (CMC)
  11. Submission type
    SUPPL
    Submission number
    7
    Submission status
    AP
    Submission status date
    20020510
    Review priority
    STANDARD
    Submission class code
    MANUF (CMC)
    Submission class code description
    Manufacturing (CMC)
    Application docs
    1. ID
      3689
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20899scm007ltr.pdf
      Date
      20020510
      Type
      Letter
    2. ID
      13698
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/020899s007lbl.pdf
      Date
      20071004
      Type
      Label
  12. Submission type
    SUPPL
    Submission number
    10
    Submission status
    AP
    Submission status date
    20071108
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Application docs
    1. ID
      3690
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020899s010ltr.pdf
      Date
      20071119
      Type
      Letter
  13. +6 more not shown
Products
  1. Product number
    001
    Reference drug
    Yes
    Brand name
    OPTISON
    Reference standard
    Yes
    Dosage form
    INJECTABLE
    Route
    INJECTION
    Marketing status
    Prescription
    Active ingredients
    1. Name
      ALBUMIN HUMAN
      Strength
      10MG/ML
Harmonized identifiers (openFDA)
Application number
NDA020899
Brand name
OPTISON PERFLUTREN PROTEIN-TYPE A MICROSPHERES
Generic name
HUMAN ALBUMIN MICROSPHERES AND PERFLUTREN
Manufacturer name
GE Healthcare Inc.
Product NDC
0407-2707
Product type
HUMAN PRESCRIPTION DRUG
Route
INTRAVENOUS
Substance name
HUMAN ALBUMIN MICROSPHERES, PERFLUTREN
SPL ID
37a56077-bf10-4afa-b405-7f80967f41e6
SPL set ID
46bcf276-d423-408a-a410-f11383406a94
Package NDC
0407-2707-03, 0407-2707-18
Nui
N0000175864, N0000010259
Pharm class epc
Contrast Agent for Ultrasound Imaging [EPC]
Pharm class moa
Ultrasound Contrast Activity [MoA]
UNII
T8C6W1N6NW, CK0N3WH0SR
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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.