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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206648
Company: TEVA PHARMS USA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TREPROSTINIL TREPROSTINIL 1MG/ML INJECTABLE;INTRAVENOUS, SUBCUTANEOUS Prescription AP No No
TREPROSTINIL TREPROSTINIL 2.5MG/ML INJECTABLE;INTRAVENOUS, SUBCUTANEOUS Prescription AP No No
TREPROSTINIL TREPROSTINIL 5MG/ML INJECTABLE;INTRAVENOUS, SUBCUTANEOUS Prescription AP No No
TREPROSTINIL TREPROSTINIL 10MG/ML INJECTABLE;INTRAVENOUS, 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
09/26/2019 ORIG-1 Approval STANDARD

Label is not available on this site.

TREPROSTINIL

INJECTABLE;INTRAVENOUS, 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;INTRAVENOUS, SUBCUTANEOUS Prescription Yes AP 021272 UNITED THERAP
TREPROSTINIL TREPROSTINIL 1MG/ML INJECTABLE;INTRAVENOUS, SUBCUTANEOUS Prescription No AP 211574 ALEMBIC GLOBAL
TREPROSTINIL TREPROSTINIL 1MG/ML INJECTABLE;INTRAVENOUS, SUBCUTANEOUS Prescription No AP 210214 DR REDDYS
TREPROSTINIL TREPROSTINIL 1MG/ML INJECTABLE;INTRAVENOUS, SUBCUTANEOUS Prescription No AP 203649 SANDOZ
TREPROSTINIL TREPROSTINIL 1MG/ML INJECTABLE;INTRAVENOUS, SUBCUTANEOUS Prescription No AP 206648 TEVA PHARMS USA

INJECTABLE;INTRAVENOUS, 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;INTRAVENOUS, SUBCUTANEOUS Prescription Yes AP 021272 UNITED THERAP
TREPROSTINIL TREPROSTINIL 2.5MG/ML INJECTABLE;INTRAVENOUS, SUBCUTANEOUS Prescription No AP 211574 ALEMBIC GLOBAL
TREPROSTINIL TREPROSTINIL 2.5MG/ML INJECTABLE;INTRAVENOUS, SUBCUTANEOUS Prescription No AP 210214 DR REDDYS
TREPROSTINIL TREPROSTINIL 2.5MG/ML INJECTABLE;INTRAVENOUS, SUBCUTANEOUS Prescription No AP 203649 SANDOZ
TREPROSTINIL TREPROSTINIL 2.5MG/ML INJECTABLE;INTRAVENOUS, SUBCUTANEOUS Prescription No AP 206648 TEVA PHARMS USA

INJECTABLE;INTRAVENOUS, 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;INTRAVENOUS, SUBCUTANEOUS Prescription Yes AP 021272 UNITED THERAP
TREPROSTINIL TREPROSTINIL 5MG/ML INJECTABLE;INTRAVENOUS, SUBCUTANEOUS Prescription No AP 211574 ALEMBIC GLOBAL
TREPROSTINIL TREPROSTINIL 5MG/ML INJECTABLE;INTRAVENOUS, SUBCUTANEOUS Prescription No AP 210214 DR REDDYS
TREPROSTINIL TREPROSTINIL 5MG/ML INJECTABLE;INTRAVENOUS, SUBCUTANEOUS Prescription No AP 203649 SANDOZ
TREPROSTINIL TREPROSTINIL 5MG/ML INJECTABLE;INTRAVENOUS, SUBCUTANEOUS Prescription No AP 206648 TEVA PHARMS USA

INJECTABLE;INTRAVENOUS, 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;INTRAVENOUS, SUBCUTANEOUS Prescription Yes AP 021272 UNITED THERAP
TREPROSTINIL TREPROSTINIL 10MG/ML INJECTABLE;INTRAVENOUS, SUBCUTANEOUS Prescription No AP 211574 ALEMBIC GLOBAL
TREPROSTINIL TREPROSTINIL 10MG/ML INJECTABLE;INTRAVENOUS, SUBCUTANEOUS Prescription No AP 210214 DR REDDYS
TREPROSTINIL TREPROSTINIL 10MG/ML INJECTABLE;INTRAVENOUS, SUBCUTANEOUS Prescription No AP 203649 SANDOZ
TREPROSTINIL TREPROSTINIL 10MG/ML INJECTABLE;INTRAVENOUS, SUBCUTANEOUS Prescription No AP 206648 TEVA PHARMS USA
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