Approvals (Drugs@FDA)

THIAMINE HYDROCHLORIDE

GLAND · THIAMINE HYDROCHLORIDE

ANDA217800Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA217800
Sponsor name
GLAND
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20250224
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
Products
  1. Product number
    001
    Reference drug
    No
    Brand name
    THIAMINE HYDROCHLORIDE
    Reference standard
    No
    Dosage form
    INJECTABLE
    Route
    INJECTION
    Marketing status
    Prescription
    Te code
    AP
    Active ingredients
    1. Name
      THIAMINE HYDROCHLORIDE
      Strength
      100MG/ML
Harmonized identifiers (openFDA)
Application number
ANDA217800
Brand name
THIAMINE HYDROCHLORIDE
Generic name
THIAMINE HYDROCHLORIDE
Manufacturer name
Gland Pharma Limited
Product NDC
68083-567
Product type
HUMAN PRESCRIPTION DRUG
Route
INTRAMUSCULAR, INTRAVENOUS
Substance name
THIAMINE HYDROCHLORIDE
RxCUI
313324
SPL ID
809c6495-dfc8-4a9e-ab98-9a5e607075ab
SPL set ID
fc0265cd-d13a-477c-8c2c-8d44fd86444e
Package NDC
68083-567-25
UNII
M572600E5P
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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.