Approvals (Drugs@FDA)

SUGAMMADEX SODIUM

MSN · SUGAMMADEX SODIUM

ANDA214368Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA214368
Sponsor name
MSN
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
      76687
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/214368Orig1s000TAltr.pdf
      Date
      20231129
      Type
      Letter
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
ANDA214368
Brand name
SUGAMMADEX
Generic name
SUGAMMADEX
Manufacturer name
Novadoz Pharmaceuticals LLC
Product NDC
72205-478, 72205-479
Product type
HUMAN PRESCRIPTION DRUG
Route
INTRAVENOUS
Substance name
SUGAMMADEX SODIUM
RxCUI
1726992, 1727000
SPL ID
63a0cffd-e2d7-4511-9ab8-923e26981e8e
SPL set ID
ab41ea1c-266f-421c-8fc4-6e7ff518a75d
Package NDC
72205-478-01, 72205-478-02, 72205-479-01, 72205-479-02
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.