Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020148
Company: BAUSCH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MIGRANAL DIHYDROERGOTAMINE MESYLATE 0.5MG/SPRAY SPRAY, METERED;NASAL Prescription AB 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
12/08/1997 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/NDA/97/020148_migranal_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/01/2019 SUPPL-25 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020148Orig1s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020148Orig1s025ltr.pdf
08/14/2014 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

12/04/2001 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

11/05/2001 SUPPL-14 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/31/2001 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

04/02/2001 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

11/30/2000 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

05/16/2000 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

07/31/2002 SUPPL-8 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20148s7s8lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/05929slr032,033and20148slr007,008ltr.pdf
07/31/2002 SUPPL-7 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20148s7s8lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/05929slr032,033and20148slr007,008ltr.pdf
01/19/1999 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

10/30/1998 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

06/26/1998 SUPPL-1 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
08/01/2019 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020148Orig1s025lbl.pdf
07/31/2002 SUPPL-8 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20148s7s8lbl.pdf
07/31/2002 SUPPL-7 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20148s7s8lbl.pdf

MIGRANAL

SPRAY, METERED;NASAL; 0.5MG/SPRAY
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DIHYDROERGOTAMINE MESYLATE DIHYDROERGOTAMINE MESYLATE 0.5MG/SPRAY SPRAY, METERED;NASAL Prescription No AB 212907 CIPLA
DIHYDROERGOTAMINE MESYLATE DIHYDROERGOTAMINE MESYLATE 0.5MG/SPRAY SPRAY, METERED;NASAL Prescription No AB 211393 CUSTOPHARM INC
MIGRANAL DIHYDROERGOTAMINE MESYLATE 0.5MG/SPRAY SPRAY, METERED;NASAL Prescription Yes AB 020148 BAUSCH

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