Approvals (Drugs@FDA)

SUGAMMADEX SODIUM

ZENARA · SUGAMMADEX SODIUM

ANDA214306Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA214306
Sponsor name
ZENARA
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20260728
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
Products
  1. 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)
  2. 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)
Harmonized identifiers (openFDA)
Application number
ANDA214306
Brand name
SUGAMMADEX
Generic name
SUGAMMADEX
Manufacturer name
Accord Healthcare Inc.
Product NDC
16729-726, 16729-727
Product type
HUMAN PRESCRIPTION DRUG
Route
INTRAVENOUS
Substance name
SUGAMMADEX SODIUM
RxCUI
1726992, 1727000
SPL ID
584eff57-3033-e86e-e063-6394a90aa30f
SPL set ID
57bf9b96-0550-b8e4-e063-6294a90a317b
Package NDC
16729-726-03, 16729-727-03
UNII
ERJ6X2MXV7
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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.