Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074454
Company: COSETTE
Company: COSETTE
| 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 |
|---|---|---|---|---|---|---|---|
| 09/25/1995 | 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 |
|---|---|---|---|---|---|
| 06/10/2015 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 12/03/2002 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/18/2001 | SUPPL-10 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/16/2000 | SUPPL-8 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/13/1999 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 07/07/1999 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/07/1999 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 07/07/1999 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/12/1999 | SUPPL-2 | Labeling |
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 |