Approvals (Drugs@FDA)

LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE

B BRAUN MEDICAL · EPINEPHRINE, LIDOCAINE HYDROCHLORIDE

ANDA208475Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA208475
Sponsor name
B BRAUN MEDICAL
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20210908
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
  2. Submission type
    SUPPL
    Submission number
    1
    Submission status
    AP
    Submission status date
    20260901
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
Products
  1. Product number
    001
    Reference drug
    No
    Brand name
    LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE
    Reference standard
    No
    Dosage form
    INJECTABLE
    Route
    INJECTION
    Marketing status
    Prescription
    Te code
    AP
    Active ingredients
    1. Name
      EPINEPHRINE
      Strength
      0.005MG/ML
    2. Name
      LIDOCAINE HYDROCHLORIDE
      Strength
      1.5%
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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.