Approvals (Drugs@FDA)

EPINEPHRINE

ZYDUS PHARMS · EPINEPHRINE

ANDA219832Generic (ANDA)Prescription
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Application number
ANDA219832
Sponsor name
ZYDUS PHARMS
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20260914
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
Products
  1. Product number
    001
    Reference drug
    No
    Brand name
    EPINEPHRINE
    Reference standard
    No
    Dosage form
    SOLUTION
    Route
    INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
    Marketing status
    Prescription
    Te code
    AP
    Active ingredients
    1. Name
      EPINEPHRINE
      Strength
      EQ 30MG BASE/30ML (EQ 1MG BASE/ML)
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