Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 203649
Company: SANDOZ INC
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
11/30/2017 ORIG-1 Approval Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203649Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203649Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/20/2018 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

11/20/2018 SUPPL-4 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

11/20/2018 SUPPL-2 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

04/18/2018 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/30/2017 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203649Orig1s000lbl.pdf

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 209382 PAR STERILE PRODUCTS
TREPROSTINIL TREPROSTINIL 1MG/ML INJECTABLE;IV (INFUSION), SUBCUTANEOUS Prescription No AP 203649 SANDOZ INC
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 209382 PAR STERILE PRODUCTS
TREPROSTINIL TREPROSTINIL 2.5MG/ML INJECTABLE;IV (INFUSION), SUBCUTANEOUS Prescription No AP 203649 SANDOZ INC
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 209382 PAR STERILE PRODUCTS
TREPROSTINIL TREPROSTINIL 5MG/ML INJECTABLE;IV (INFUSION), SUBCUTANEOUS Prescription No AP 203649 SANDOZ INC
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 209382 PAR STERILE PRODUCTS
TREPROSTINIL TREPROSTINIL 10MG/ML INJECTABLE;IV (INFUSION), SUBCUTANEOUS Prescription No AP 203649 SANDOZ INC
TREPROSTINIL TREPROSTINIL 10MG/ML INJECTABLE;IV (INFUSION), SUBCUTANEOUS Prescription No AP 206648 TEVA PHARMS USA

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