Approvals (Drugs@FDA)

DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE

HQ SPCLT PHARMA · DILTIAZEM HYDROCHLORIDE

NDA218038Drug (NDA)Prescription
Open FDA's page for this record
Application number
NDA218038
Sponsor name
HQ SPCLT PHARMA
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20250221
    Review priority
    STANDARD
    Submission class code
    TYPE 5
    Submission class code description
    Type 5 - New Formulation or New Manufacturer
    Application docs
    1. ID
      81330
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/218038s000lbl.pdf
      Date
      20250224
      Type
      Label
    2. ID
      81363
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/218038Orig1s000ltr.pdf
      Date
      20250225
      Type
      Letter
    3. ID
      84172
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/218038Orig1s000TOC.html
      Date
      20251117
      Type
      Review
Products
  1. Product number
    002
    Reference drug
    Yes
    Brand name
    DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE
    Reference standard
    Yes
    Dosage form
    SOLUTION
    Route
    INTRAVENOUS
    Marketing status
    Prescription
    Active ingredients
    1. Name
      DILTIAZEM HYDROCHLORIDE
      Strength
      250MG/250ML (1MG/ML)
  2. Product number
    001
    Reference drug
    Yes
    Brand name
    DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE
    Reference standard
    Yes
    Dosage form
    SOLUTION
    Route
    INTRAVENOUS
    Marketing status
    Prescription
    Active ingredients
    1. Name
      DILTIAZEM HYDROCHLORIDE
      Strength
      100MG/100ML (1MG/ML)
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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.