Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 079241
Company: AMNEAL PHARMS
Company: AMNEAL PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ALBUTEROL SULFATE | ALBUTEROL SULFATE | EQ 2MG BASE/5ML | SYRUP;ORAL | Prescription | AA | 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 |
---|---|---|---|---|---|---|---|
05/12/2010 | ORIG-1 | Approval |
Label is not available on this site. |
ALBUTEROL SULFATE
SYRUP;ORAL; EQ 2MG BASE/5ML
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ALBUTEROL SULFATE | ALBUTEROL SULFATE | EQ 2MG BASE/5ML | SYRUP;ORAL | Prescription | No | AA | 079241 | AMNEAL PHARMS |
ALBUTEROL SULFATE | ALBUTEROL SULFATE | EQ 2MG BASE/5ML | SYRUP;ORAL | Prescription | No | AA | 078105 | CHARTWELL MOLECULAR |
ALBUTEROL SULFATE | ALBUTEROL SULFATE | EQ 2MG BASE/5ML | SYRUP;ORAL | Prescription | No | AA | 077788 | CHARTWELL RX |
ALBUTEROL SULFATE | ALBUTEROL SULFATE | EQ 2MG BASE/5ML | SYRUP;ORAL | Prescription | No | AA | 074454 | COSETTE |
ALBUTEROL SULFATE | ALBUTEROL SULFATE | EQ 2MG BASE/5ML | SYRUP;ORAL | Prescription | No | AA | 212197 | QUAGEN |
ALBUTEROL SULFATE | ALBUTEROL SULFATE | EQ 2MG BASE/5ML | SYRUP;ORAL | Prescription | No | AA | 073419 | TEVA |