Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 005929
Company: BAUSCH
Company: BAUSCH
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| D.H.E. 45 | DIHYDROERGOTAMINE MESYLATE | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 04/12/1946 | ORIG-1 | Approval | UNKNOWN |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/09/2022 | SUPPL-45 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/005929s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/005929Orig1s045ltr.pdf | |
| 09/01/2009 | SUPPL-44 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/005929s044lbl.pdf | |
| 12/04/2001 | SUPPL-40 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/03/2001 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/02/2001 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/19/2000 | SUPPL-37 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/30/2000 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/16/2000 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/31/2002 | SUPPL-33 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/05929s32s33lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/05929slr032,033and20148slr007,008ltr.pdf | |
| 07/31/2002 | SUPPL-32 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/05929s32s33lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/05929slr032,033and20148slr007,008ltr.pdf | |
| 01/19/1999 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/07/1997 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/10/1995 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/23/1994 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 01/29/1998 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 01/29/1998 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 03/09/1993 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/07/1992 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/04/1990 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/22/1989 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/02/1988 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/24/1983 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/08/1987 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/15/1982 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/27/1981 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/31/1979 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/09/2022 | SUPPL-45 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/005929s045lbl.pdf | |
| 05/09/2022 | SUPPL-45 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/005929s045lbl.pdf | |
| 09/01/2009 | SUPPL-44 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/005929s044lbl.pdf | |
| 09/01/2009 | SUPPL-44 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/005929s044lbl.pdf | |
| 07/31/2002 | SUPPL-33 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/05929s32s33lbl.pdf | |
| 07/31/2002 | SUPPL-32 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/05929s32s33lbl.pdf |