Approvals (Drugs@FDA)

TERIPARATIDE

ALMAJECT · TERIPARATIDE

NDA218771Drug (NDA)Prescription
Open FDA's page for this record
Application number
NDA218771
Sponsor name
ALMAJECT
Submissions
  1. Submission type
    SUPPL
    Submission number
    1
    Submission status
    AP
    Submission status date
    20250123
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Application docs
    1. ID
      81034
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/218771Orig1s001lbl.pdf
      Date
      20250206
      Type
      Label
    2. ID
      81103
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/218771Orig1s001ltr.pdf
      Date
      20250206
      Type
      Letter
  2. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20240604
    Review priority
    STANDARD
    Submission class code
    TYPE 5
    Submission class code description
    Type 5 - New Formulation or New Manufacturer
    Application docs
    1. ID
      78639
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/218771Orig1s000ltr.pdf
      Date
      20240702
      Type
      Letter
    2. ID
      78650
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218771s000lbl.pdf
      Date
      20240605
      Type
      Label
    3. ID
      80909
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/218771Orig1s000TOC.html
      Date
      20250204
      Type
      Review
  3. Submission type
    SUPPL
    Submission number
    2
    Submission status
    AP
    Submission status date
    20260803
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Application docs
    1. ID
      86823
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/218771Orig1s002ltr.pdf
      Date
      20260806
      Type
      Letter
    2. ID
      86857
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/218771s002lbl.pdf
      Date
      20260811
      Type
      Label
    3. ID
      86858
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/218771s002lbl.pdf#page=20
      Date
      20260811
      Type
      Medication Guide
Products
  1. Product number
    001
    Reference drug
    Yes
    Brand name
    TERIPARATIDE
    Reference standard
    Yes
    Dosage form
    SOLUTION
    Route
    SUBCUTANEOUS
    Marketing status
    Prescription
    Te code
    AP
    Active ingredients
    1. Name
      TERIPARATIDE
      Strength
      0.56MG/2.24ML (0.25MG/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.