Approvals (Drugs@FDA)

SUCCINYLCHOLINE CHLORIDE

FRESENIUS KABI USA · SUCCINYLCHOLINE CHLORIDE

ANDA217885Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA217885
Sponsor name
FRESENIUS KABI USA
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20250221
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
Products
  1. Product number
    001
    Reference drug
    No
    Brand name
    SUCCINYLCHOLINE CHLORIDE
    Reference standard
    No
    Dosage form
    INJECTABLE
    Route
    INJECTION
    Marketing status
    Prescription
    Te code
    AP
    Active ingredients
    1. Name
      SUCCINYLCHOLINE CHLORIDE
      Strength
      20MG/ML
Harmonized identifiers (openFDA)
Application number
ANDA217885
Brand name
SUCCINYLCHOLINE CHLORIDE
Generic name
SUCCINYLCHOLINE CHLORIDE
Manufacturer name
Fresenius Kabi USA LLC
Product NDC
65219-276
Product type
HUMAN PRESCRIPTION DRUG
Route
INTRAMUSCULAR, INTRAVENOUS
Substance name
SUCCINYLCHOLINE CHLORIDE DIHYDRATE
RxCUI
2694114
SPL ID
fdf858c8-71c8-4870-8e5f-baaeb54cde6d
SPL set ID
ce12d907-eae4-4fba-b85e-170fac1819c6
Package NDC
65219-276-01, 65219-276-10
UNII
8L0S1G435E
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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.