Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078630
Company: HIKMA FARMACEUTICA
Company: HIKMA FARMACEUTICA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TERBUTALINE SULFATE | TERBUTALINE SULFATE | 1MG/ML | INJECTABLE;INJECTION | Prescription | AP | No | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
05/20/2009 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/08/2011 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
TERBUTALINE SULFATE
INJECTABLE;INJECTION; 1MG/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
TERBUTALINE SULFATE | TERBUTALINE SULFATE | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 200122 | AREVA PHARMS |
TERBUTALINE SULFATE | TERBUTALINE SULFATE | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 076887 | FRESENIUS KABI USA |
TERBUTALINE SULFATE | TERBUTALINE SULFATE | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 078630 | HIKMA FARMACEUTICA |