Approvals (Drugs@FDA)

SUGAMMADEX SODIUM

STERISCIENCE · SUGAMMADEX SODIUM

ANDA218814Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA218814
Sponsor name
STERISCIENCE
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
    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)
Harmonized identifiers (openFDA)
Application number
ANDA218814
Brand name
SUGAMMADEX SODIUM
Generic name
SUGAMMADEX SODIUM
Manufacturer name
Par Health USA, LLC, STERISCIENCE SPECIALTIES PRIVATE LIMITED
Product NDC
42023-830, 42023-935, 82449-241, 82449-242
Product type
HUMAN PRESCRIPTION DRUG
Route
INTRAVENOUS
Substance name
SUGAMMADEX SODIUM
RxCUI
2748156, 2748158
SPL ID
57d27f48-e8f1-531b-e063-6294a90ac2cb, 57d290a8-9981-69a9-e063-6294a90ad9e2
SPL set ID
579a2a1f-4d0c-4851-e063-6294a90a2be6, 0379799d-b678-4eb1-8f15-7dd183ee2a6e
Package NDC
42023-830-10, 42023-935-10, 82449-241-02, 82449-242-02
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.