Drugs@FDA: FDA-Approved Drugs
Company: DELCOR ASSET CORP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PHENERGAN | PROMETHAZINE HYDROCHLORIDE | 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
PHENERGAN | PROMETHAZINE HYDROCHLORIDE | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
PHENERGAN | PROMETHAZINE HYDROCHLORIDE | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|---|---|
03/29/1951 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/08/2004 | SUPPL-30 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/07935s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/07935s030ltr.pdf | |
03/13/2009 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
12/26/2002 | SUPPL-28 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/07935slr025,026,028ltr.pdf |
03/13/2009 | SUPPL-26 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/07935slr025,026,028ltr.pdf |
03/13/2009 | SUPPL-25 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/07935slr025,026,028ltr.pdf |
03/30/1992 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/13/2009 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
06/30/1988 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
11/21/1989 | SUPPL-21 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
04/07/1988 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
01/22/1988 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
05/31/1988 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
12/11/1989 | SUPPL-16 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
03/19/1987 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
03/13/2009 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
05/29/1986 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
03/13/2009 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
03/13/2009 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
03/13/2009 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
03/13/2009 | SUPPL-4 | Labeling |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
11/08/2004 | SUPPL-30 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/07935s030lbl.pdf |