Drugs@FDA: FDA-Approved Drugs
Company: G AND W LABS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PROMETH W/ DEXTROMETHORPHAN | DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE | 15MG/5ML;6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP;ORAL | Discontinued | None | No | No |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 |
|---|---|---|---|---|---|---|---|
| 10/31/1984 | 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 |
|---|---|---|---|---|---|
| 11/02/2015 | SUPPL-74 | Labeling |
Label is not available on this site. |
||
| 12/05/2005 | SUPPL-60 | Labeling |
Label is not available on this site. |
||
| 05/02/2005 | SUPPL-55 | Labeling |
Label is not available on this site. |
||
| 06/06/2003 | SUPPL-52 | Labeling |
Label is not available on this site. |
||
| 10/03/2001 | SUPPL-51 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/03/2001 | SUPPL-50 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/02/2000 | SUPPL-49 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/01/2000 | SUPPL-46 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 08/01/2000 | SUPPL-45 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/01/1998 | SUPPL-44 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/01/1998 | SUPPL-43 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/22/1997 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/18/1996 | SUPPL-40 | Labeling |
Label is not available on this site. |
||
| 06/18/1996 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/07/1996 | SUPPL-37 | Labeling |
Label is not available on this site. |
||
| 05/07/1996 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/07/1996 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/23/1995 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/07/1996 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/07/1996 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/30/1996 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/30/1996 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/02/1994 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/04/1993 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/14/1992 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/23/1991 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/23/1991 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/23/1991 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/28/1990 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/22/1991 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 03/26/1990 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 10/03/1990 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/03/1990 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/03/1990 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/03/1990 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/19/1989 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 05/31/1989 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/31/1989 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/15/1988 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/15/1988 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/02/1988 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 03/17/1987 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/09/1987 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/05/1986 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |