Drugs@FDA: FDA-Approved Drugs
Company: NOSTRUM LABS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PROMETH VC W/ CODEINE | CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE | 10MG/5ML;5MG/5ML;6.25MG/5ML | 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 |
|---|---|---|---|---|---|
| 12/15/2023 | SUPPL-89 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/28/2018 | SUPPL-88 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/08/2018 | SUPPL-87 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 08/29/2017 | SUPPL-86 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 01/13/2017 | SUPPL-85 | Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 05/10/2013 | SUPPL-84 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/088764Orig1s084lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/088764Orig1s084ltr.pdf | |
| 05/03/2013 | SUPPL-81 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/20/2009 | SUPPL-77 | Labeling |
Label is not available on this site. |
||
| 08/01/2011 | SUPPL-75 | Labeling |
Label is not available on this site. |
||
| 10/06/2005 | SUPPL-63 | Labeling |
Label is not available on this site. |
||
| 05/02/2005 | SUPPL-53 | Labeling |
Label is not available on this site. |
||
| 06/06/2003 | SUPPL-49 | Labeling |
Label is not available on this site. |
||
| 07/15/2002 | SUPPL-48 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/03/2001 | SUPPL-47 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/03/2001 | SUPPL-46 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/02/2000 | SUPPL-45 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/01/1998 | SUPPL-42 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/05/1998 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/05/1998 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/05/1998 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/02/1997 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/07/1997 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/18/1996 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/07/1996 | SUPPL-34 | Labeling |
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. |
||
| 10/23/1995 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/07/1996 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/07/1996 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/30/1996 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/30/1996 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/02/1994 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/12/1992 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 01/23/1991 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/28/1990 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/08/1991 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 03/29/1990 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 02/07/1990 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 11/06/1989 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 10/03/1990 | SUPPL-17 | 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. |
||
| 12/15/1988 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/09/1988 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/17/1987 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/19/1986 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/28/1987 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/28/1987 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/18/1986 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/14/1985 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/10/2013 | SUPPL-84 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/088764Orig1s084lbl.pdf |