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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209382
Company: PAR STERILE PRODUCTS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TREPROSTINIL TREPROSTINIL 1MG/ML INJECTABLE;IV (INFUSION), SUBCUTANEOUS Prescription AP No No
TREPROSTINIL TREPROSTINIL 2.5MG/ML INJECTABLE;IV (INFUSION), SUBCUTANEOUS Prescription AP No No
TREPROSTINIL TREPROSTINIL 5MG/ML INJECTABLE;IV (INFUSION), SUBCUTANEOUS Prescription AP No No
TREPROSTINIL TREPROSTINIL 10MG/ML INJECTABLE;IV (INFUSION), SUBCUTANEOUS Prescription AP No No

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/24/2019 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209382Orig1s000TAltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/27/2022 SUPPL-4 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

TREPROSTINIL

INJECTABLE;IV (INFUSION), SUBCUTANEOUS; 1MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
REMODULIN TREPROSTINIL 1MG/ML INJECTABLE;IV (INFUSION), SUBCUTANEOUS Prescription Yes AP 021272 UNITED THERAP
TREPROSTINIL TREPROSTINIL 1MG/ML INJECTABLE;IV (INFUSION), SUBCUTANEOUS Prescription No AP 211574 ALEMBIC GLOBAL
TREPROSTINIL TREPROSTINIL 1MG/ML INJECTABLE;IV (INFUSION), SUBCUTANEOUS Prescription No AP 210214 DR REDDYS
TREPROSTINIL TREPROSTINIL 1MG/ML INJECTABLE;IV (INFUSION), SUBCUTANEOUS Prescription No AP 209382 PAR STERILE PRODUCTS
TREPROSTINIL TREPROSTINIL 1MG/ML INJECTABLE;IV (INFUSION), SUBCUTANEOUS Prescription No AP 203649 SANDOZ
TREPROSTINIL TREPROSTINIL 1MG/ML INJECTABLE;IV (INFUSION), SUBCUTANEOUS Prescription No AP 206648 TEVA PHARMS USA

INJECTABLE;IV (INFUSION), SUBCUTANEOUS; 2.5MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
REMODULIN TREPROSTINIL 2.5MG/ML INJECTABLE;IV (INFUSION), SUBCUTANEOUS Prescription Yes AP 021272 UNITED THERAP
TREPROSTINIL TREPROSTINIL 2.5MG/ML INJECTABLE;IV (INFUSION), SUBCUTANEOUS Prescription No AP 211574 ALEMBIC GLOBAL
TREPROSTINIL TREPROSTINIL 2.5MG/ML INJECTABLE;IV (INFUSION), SUBCUTANEOUS Prescription No AP 210214 DR REDDYS
TREPROSTINIL TREPROSTINIL 2.5MG/ML INJECTABLE;IV (INFUSION), SUBCUTANEOUS Prescription No AP 209382 PAR STERILE PRODUCTS
TREPROSTINIL TREPROSTINIL 2.5MG/ML INJECTABLE;IV (INFUSION), SUBCUTANEOUS Prescription No AP 203649 SANDOZ
TREPROSTINIL TREPROSTINIL 2.5MG/ML INJECTABLE;IV (INFUSION), SUBCUTANEOUS Prescription No AP 206648 TEVA PHARMS USA

INJECTABLE;IV (INFUSION), SUBCUTANEOUS; 5MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
REMODULIN TREPROSTINIL 5MG/ML INJECTABLE;IV (INFUSION), SUBCUTANEOUS Prescription Yes AP 021272 UNITED THERAP
TREPROSTINIL TREPROSTINIL 5MG/ML INJECTABLE;IV (INFUSION), SUBCUTANEOUS Prescription No AP 211574 ALEMBIC GLOBAL
TREPROSTINIL TREPROSTINIL 5MG/ML INJECTABLE;IV (INFUSION), SUBCUTANEOUS Prescription No AP 210214 DR REDDYS
TREPROSTINIL TREPROSTINIL 5MG/ML INJECTABLE;IV (INFUSION), SUBCUTANEOUS Prescription No AP 209382 PAR STERILE PRODUCTS
TREPROSTINIL TREPROSTINIL 5MG/ML INJECTABLE;IV (INFUSION), SUBCUTANEOUS Prescription No AP 203649 SANDOZ
TREPROSTINIL TREPROSTINIL 5MG/ML INJECTABLE;IV (INFUSION), SUBCUTANEOUS Prescription No AP 206648 TEVA PHARMS USA

INJECTABLE;IV (INFUSION), SUBCUTANEOUS; 10MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
REMODULIN TREPROSTINIL 10MG/ML INJECTABLE;IV (INFUSION), SUBCUTANEOUS Prescription Yes AP 021272 UNITED THERAP
TREPROSTINIL TREPROSTINIL 10MG/ML INJECTABLE;IV (INFUSION), SUBCUTANEOUS Prescription No AP 211574 ALEMBIC GLOBAL
TREPROSTINIL TREPROSTINIL 10MG/ML INJECTABLE;IV (INFUSION), SUBCUTANEOUS Prescription No AP 210214 DR REDDYS
TREPROSTINIL TREPROSTINIL 10MG/ML INJECTABLE;IV (INFUSION), SUBCUTANEOUS Prescription No AP 209382 PAR STERILE PRODUCTS
TREPROSTINIL TREPROSTINIL 10MG/ML INJECTABLE;IV (INFUSION), SUBCUTANEOUS Prescription No AP 203649 SANDOZ
TREPROSTINIL TREPROSTINIL 10MG/ML INJECTABLE;IV (INFUSION), SUBCUTANEOUS Prescription No AP 206648 TEVA PHARMS USA
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