U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 218771
Company: ALMAJECT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TERIPARATIDE TERIPARATIDE 0.56MG/2.24ML (0.25MG/ML) SOLUTION;SUBCUTANEOUS Prescription AP Yes Yes

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/04/2024 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218771s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/218771Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/218771Orig1s000TOC.html
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/23/2025 SUPPL-1 Labeling-Package Insert, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/218771Orig1s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/218771Orig1s001ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/218771Orig1s001ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
01/23/2025 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/218771Orig1s001lbl.pdf
01/23/2025 SUPPL-1 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/218771Orig1s001lbl.pdf
06/04/2024 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218771s000lbl.pdf

TERIPARATIDE

SOLUTION;SUBCUTANEOUS; 0.56MG/2.24ML (0.25MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FORTEO TERIPARATIDE 0.56MG/2.24ML (0.25MG/ML) SOLUTION;SUBCUTANEOUS Prescription Yes AP 021318 LILLY
TERIPARATIDE TERIPARATIDE 0.56MG/2.24ML (0.25MG/ML) SOLUTION;SUBCUTANEOUS Prescription Yes AP 218771 ALMAJECT
TERIPARATIDE TERIPARATIDE 0.56MG/2.24ML (0.25MG/ML) SOLUTION;SUBCUTANEOUS Prescription No AP 213641 AMPHASTAR PHARMS INC
TERIPARATIDE TERIPARATIDE 0.56MG/2.24ML (0.25MG/ML) SOLUTION;SUBCUTANEOUS Prescription No AP 211097 APOTEX
TERIPARATIDE TERIPARATIDE 0.56MG/2.24ML (0.25MG/ML) SOLUTION;SUBCUTANEOUS Prescription No AP 208569 TEVA PHARMS USA
Back to Top