Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 005929
Company: BAUSCH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
D.H.E. 45 DIHYDROERGOTAMINE MESYLATE 1MG/ML INJECTABLE;INJECTION Prescription AP Yes Yes
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
09/01/2009 SUPPL-44 Labeling-Package Insert, Labeling-Container/Carton Labels 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
09/01/2009 SUPPL-44 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/005929s044lbl.pdf
09/01/2009 SUPPL-44 Labeling-Container/Carton Labels 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

D.H.E. 45

INJECTABLE;INJECTION; 1MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
D.H.E. 45 DIHYDROERGOTAMINE MESYLATE 1MG/ML INJECTABLE;INJECTION Prescription Yes AP 005929 BAUSCH
DIHYDROERGOTAMINE MESYLATE DIHYDROERGOTAMINE MESYLATE 1MG/ML INJECTABLE;INJECTION Prescription No AP 206621 HIKMA PHARMS
DIHYDROERGOTAMINE MESYLATE DIHYDROERGOTAMINE MESYLATE 1MG/ML INJECTABLE;INJECTION Prescription No AP 040475 PADDOCK LLC
DIHYDROERGOTAMINE MESYLATE DIHYDROERGOTAMINE MESYLATE 1MG/ML INJECTABLE;INJECTION Prescription No AP 207264 SAGENT PHARMS INC
DIHYDROERGOTAMINE MESYLATE DIHYDROERGOTAMINE MESYLATE 1MG/ML INJECTABLE;INJECTION Prescription No AP 040453 WEST-WARD PHARMS INT

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