Drugs@FDA: FDA-Approved Drugs
Company: TEVA
| 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 | 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 |
|---|---|---|---|---|---|---|---|
| 03/30/1992 | 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 |
|---|---|---|---|---|---|
| 08/30/2001 | SUPPL-26 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 07/27/2000 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 07/07/2000 | SUPPL-24 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 05/06/1998 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 05/27/1998 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/27/1998 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/07/1997 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/08/1997 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/16/1996 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/12/1995 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 05/04/1995 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/04/1995 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/22/1995 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 02/02/1995 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/22/1994 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/02/1995 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/08/1994 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 12/03/1993 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/09/1993 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/01/1993 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/25/1993 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/25/1993 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/28/1993 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/30/1992 | SUPPL-2 | Manufacturing (CMC) |
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 |