Approvals (Drugs@FDA)

ROCURONIUM BROMIDE

BAXTER HLTHCARE CORP · ROCURONIUM BROMIDE

ANDA219260Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA219260
Sponsor name
BAXTER HLTHCARE CORP
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20260918
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
Products
  1. Product number
    002
    Reference drug
    No
    Brand name
    ROCURONIUM BROMIDE
    Reference standard
    No
    Dosage form
    INJECTABLE
    Route
    INJECTION
    Marketing status
    Prescription
    Te code
    AP
    Active ingredients
    1. Name
      ROCURONIUM BROMIDE
      Strength
      100MG/10ML (10MG/ML)
  2. Product number
    001
    Reference drug
    No
    Brand name
    ROCURONIUM BROMIDE
    Reference standard
    No
    Dosage form
    INJECTABLE
    Route
    INJECTION
    Marketing status
    Prescription
    Te code
    AP
    Active ingredients
    1. Name
      ROCURONIUM BROMIDE
      Strength
      50MG/5ML (10MG/ML)
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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.