Approvals (Drugs@FDA)

SUGAMMADEX SODIUM

MANKIND PHARMA · SUGAMMADEX SODIUM

ANDA214230Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA214230
Sponsor name
MANKIND PHARMA
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20260728
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
    Application docs
    1. ID
      73410
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/214230Orig1s000TA_ltr.pdf
      Date
      20240214
      Type
      Letter
Products
  1. Product number
    002
    Reference drug
    No
    Brand name
    SUGAMMADEX SODIUM
    Reference standard
    No
    Dosage form
    SOLUTION
    Route
    INTRAVENOUS
    Marketing status
    Prescription
    Te code
    AP
    Active ingredients
    1. Name
      SUGAMMADEX SODIUM
      Strength
      EQ 500MG BASE/5ML (EQ 100MG BASE/ML)
  2. Product number
    001
    Reference drug
    No
    Brand name
    SUGAMMADEX SODIUM
    Reference standard
    No
    Dosage form
    SOLUTION
    Route
    INTRAVENOUS
    Marketing status
    Prescription
    Te code
    AP
    Active ingredients
    1. Name
      SUGAMMADEX SODIUM
      Strength
      EQ 200MG BASE/2ML (EQ 100MG BASE/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.