Approvals (Drugs@FDA)

CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY

PERRIGO R AND D · CETIRIZINE HYDROCHLORIDE

ANDA090254Generic (ANDA)Over-the-counter
Open FDA's page for this record
Application number
ANDA090254
Sponsor name
PERRIGO R AND D
Submissions
  1. Submission type
    SUPPL
    Submission number
    20
    Submission status
    AP
    Submission status date
    20170710
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
  2. Submission type
    SUPPL
    Submission number
    2
    Submission status
    AP
    Submission status date
    20090528
    Submission class code
    LABELING
    Submission class code description
    Labeling
  3. Submission type
    SUPPL
    Submission number
    3
    Submission status
    AP
    Submission status date
    20100723
    Submission class code
    MANUF (CMC)
    Submission class code description
    Manufacturing (CMC)
  4. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20080409
    Application docs
    1. ID
      31459
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/090254s000ltr.pdf
      Date
      20080411
      Type
      Letter
Products
  1. Product number
    001
    Reference drug
    No
    Brand name
    CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF
    Reference standard
    No
    Dosage form
    SOLUTION
    Route
    ORAL
    Marketing status
    Over-the-counter
    Active ingredients
    1. Name
      CETIRIZINE HYDROCHLORIDE
      Strength
      5MG/5ML
  2. Product number
    002
    Reference drug
    No
    Brand name
    CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY
    Reference standard
    No
    Dosage form
    SOLUTION
    Route
    ORAL
    Marketing status
    Over-the-counter
    Active ingredients
    1. Name
      CETIRIZINE HYDROCHLORIDE
      Strength
      5MG/5ML
Harmonized identifiers (openFDA)
Application number
ANDA090254
Brand name
CETIRIZINE HYDROCHLORIDE
Generic name
CETIRIZINE HYDROCHLORIDE
Manufacturer name
Padagis Israel Pharmaceuticals Ltd
Product NDC
45802-974
Product type
HUMAN OTC DRUG
Route
ORAL
Substance name
CETIRIZINE HYDROCHLORIDE
RxCUI
1014673
SPL ID
71411b7e-4fb8-4c33-b260-287128711d0a
SPL set ID
c2cf555d-986c-4e89-ac4f-938e92c418e2
Package NDC
45802-974-26
UNII
64O047KTOA
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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.