Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 211832
Company: TWI PHARMS
Company: TWI PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TERBUTALINE SULFATE | TERBUTALINE SULFATE | 2.5MG | TABLET;ORAL | Prescription | AB | No | No |
TERBUTALINE SULFATE | TERBUTALINE SULFATE | 5MG | TABLET;ORAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
06/19/2020 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
TERBUTALINE SULFATE
TABLET;ORAL; 2.5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BRETHINE | TERBUTALINE SULFATE | 2.5MG | TABLET;ORAL | Prescription | Yes | AB | 017849 | ANI PHARMS |
TERBUTALINE SULFATE | TERBUTALINE SULFATE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 075877 | IMPAX LABS |
TERBUTALINE SULFATE | TERBUTALINE SULFATE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 077152 | LANNETT CO INC |
TERBUTALINE SULFATE | TERBUTALINE SULFATE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 211832 | TWI PHARMS |
TABLET;ORAL; 5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BRETHINE | TERBUTALINE SULFATE | 5MG | TABLET;ORAL | Prescription | Yes | AB | 017849 | ANI PHARMS |
TERBUTALINE SULFATE | TERBUTALINE SULFATE | 5MG | TABLET;ORAL | Prescription | No | AB | 075877 | IMPAX LABS |
TERBUTALINE SULFATE | TERBUTALINE SULFATE | 5MG | TABLET;ORAL | Prescription | No | AB | 077152 | LANNETT CO INC |
TERBUTALINE SULFATE | TERBUTALINE SULFATE | 5MG | TABLET;ORAL | Prescription | No | AB | 211832 | TWI PHARMS |