Drugs@FDA: FDA-Approved Drugs
Company: HERITAGE PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CYPROHEPTADINE HYDROCHLORIDE | CYPROHEPTADINE HYDROCHLORIDE | 4MG | 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 |
---|---|---|---|---|---|---|---|
01/10/1980 | 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 |
---|---|---|---|---|---|
03/20/2009 | SUPPL-45 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/087056s045lbl.pdf | |
07/29/2002 | SUPPL-37 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
10/04/2002 | SUPPL-36 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
09/12/2001 | SUPPL-35 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
10/26/2000 | SUPPL-34 | Labeling |
Label is not available on this site. |
||
07/25/2000 | SUPPL-33 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
01/28/2000 | SUPPL-32 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
09/24/1999 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/20/1999 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/24/1999 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/24/1999 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
12/09/1998 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/17/1997 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
03/10/1998 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/30/1997 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/13/1994 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/27/1989 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
11/12/1987 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/12/1987 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/06/1987 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/08/1984 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/02/1983 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/12/1982 | SUPPL-12 | 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 |
---|---|---|---|---|---|
03/20/2009 | SUPPL-45 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/087056s045lbl.pdf |