Drugs@FDA: FDA-Approved Drugs
Company: SANDOZ
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 |
---|---|---|---|---|---|
03/14/2024 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
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 | 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 |