Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 211574
Company: ALEMBIC GLOBAL
Company: ALEMBIC GLOBAL
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 |
---|---|---|---|---|---|---|---|
02/11/2021 | ORIG-1 | Approval | STANDARD |
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 | ENDO OPERATIONS |
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 | ENDO OPERATIONS |
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 | ENDO OPERATIONS |
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 | ENDO OPERATIONS |
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 |