Approvals (Drugs@FDA)

NASACORT ALLERGY 24 HOUR

CHATTEM SANOFI · TRIAMCINOLONE ACETONIDE

NDA020468Drug (NDA)Over-the-counter
Open FDA's page for this record
Application number
NDA020468
Sponsor name
CHATTEM SANOFI
Submissions
  1. Submission type
    SUPPL
    Submission number
    49
    Submission status
    AP
    Submission status date
    20250509
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Application docs
    1. ID
      82190
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/020468Orig1s049ltr.pdf
      Date
      20250515
      Type
      Letter
    2. ID
      82194
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020468Orig1s049lbl.pdf
      Date
      20250515
      Type
      Label
  2. Submission type
    SUPPL
    Submission number
    39
    Submission status
    AP
    Submission status date
    20140919
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Application docs
    1. ID
      25003
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020468Orig1s039ltr.pdf
      Date
      20140923
      Type
      Letter
    2. ID
      34680
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020468Orig1s039lbl.pdf
      Date
      20140923
      Type
      Label
  3. Submission type
    SUPPL
    Submission number
    2
    Submission status
    AP
    Submission status date
    19970926
    Review priority
    STANDARD
    Submission class code
    EFFICACY
    Submission class code description
    Efficacy
  4. Submission type
    SUPPL
    Submission number
    37
    Submission status
    AP
    Submission status date
    20131207
    Review priority
    PRIORITY
    Submission class code
    MANUF (CMC)
    Submission class code description
    Manufacturing (CMC)
  5. Submission type
    SUPPL
    Submission number
    35
    Submission status
    AP
    Submission status date
    20131011
    Review priority
    STANDARD
    Submission class code
    EFFICACY
    Submission class code description
    Efficacy
    Application docs
    1. ID
      12612
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020468Orig1s035lbl.pdf
      Date
      20131015
      Type
      Label
    2. ID
      25002
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020468Orig1s035ltr.pdf
      Date
      20131011
      Type
      Letter
  6. Submission type
    SUPPL
    Submission number
    41
    Submission status
    AP
    Submission status date
    20160322
    Review priority
    PRIORITY
    Submission class code
    MANUF (CMC)
    Submission class code description
    Manufacturing (CMC)
  7. Submission type
    SUPPL
    Submission number
    33
    Submission status
    AP
    Submission status date
    20130702
    Review priority
    STANDARD
    Submission class code
    EFFICACY
    Submission class code description
    Efficacy
    Application docs
    1. ID
      12611
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020468s033s034lbl.pdf
      Date
      20130703
      Type
      Label
    2. ID
      2570
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020468Orig1s033,s034ltr.pdf
      Date
      20130703
      Type
      Letter
  8. Submission type
    SUPPL
    Submission number
    13
    Submission status
    AP
    Submission status date
    20040308
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Application docs
    1. ID
      12609
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20468slr013_nasacort_lbl.pdf
      Date
      20040405
      Type
      Label
    2. ID
      2568
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20468slr013ltr.pdf
      Date
      20040310
      Type
      Letter
  9. Submission type
    SUPPL
    Submission number
    11
    Submission status
    AP
    Submission status date
    20031217
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Application docs
    1. ID
      12608
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20468slr011_nasacort_lbl.pdf
      Date
      20031229
      Type
      Label
    2. ID
      25000
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20468slr011ltr.pdf
      Date
      20031222
      Type
      Letter
  10. Submission type
    SUPPL
    Submission number
    7
    Submission status
    AP
    Submission status date
    20020312
    Review priority
    PRIORITY
    Submission class code
    MANUF (CMC)
    Submission class code description
    Manufacturing (CMC)
  11. Submission type
    SUPPL
    Submission number
    5
    Submission status
    AP
    Submission status date
    20000817
    Review priority
    PRIORITY
    Submission class code
    MANUF (CMC)
    Submission class code description
    Manufacturing (CMC)
  12. Submission type
    SUPPL
    Submission number
    46
    Submission status
    AP
    Submission status date
    20181017
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Application docs
    1. ID
      56055
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020468Orig1s046ltr.pdf
      Date
      20181023
      Type
      Letter
    2. ID
      56100
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020468Orig1s046lbl.pdf
      Date
      20181026
      Type
      Label
  13. +13 more not shown
Products
  1. Product number
    002
    Reference drug
    Yes
    Brand name
    NASACORT ALLERGY 24 HOUR
    Reference standard
    Yes
    Dosage form
    SPRAY, METERED
    Route
    NASAL
    Marketing status
    Over-the-counter
    Active ingredients
    1. Name
      TRIAMCINOLONE ACETONIDE
      Strength
      0.055MG/SPRAY
Harmonized identifiers (openFDA)
Application number
NDA020468
Brand name
NASACORT ALLERGY 24HR
Generic name
TRIAMCINOLONE ACETONIDE
Manufacturer name
Chattem, Inc.
Product NDC
41167-5800
Product type
HUMAN OTC DRUG
Route
NASAL
Substance name
TRIAMCINOLONE ACETONIDE
RxCUI
1797913, 1797915
SPL ID
153d24d7-d4ba-4bde-b379-6c0244482738
SPL set ID
4bff57a5-cce0-401c-a0fe-23c65c1b7ddc
Package NDC
41167-5800-7, 41167-5800-3, 41167-5800-5, 41167-5800-2, 41167-5800-1, 41167-5800-6
Nui
N0000175576, N0000175450
Pharm class epc
Corticosteroid [EPC]
Pharm class moa
Corticosteroid Hormone Receptor Agonists [MoA]
UNII
F446C597KA
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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.