An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 020148
Company: BAUSCH

Products on NDA 020148

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020148

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
05/09/2022	SUPPL-26	Labeling-Patient Package Insert, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020148s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020148Orig1s026ltr.pdf
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.

Labels for NDA 020148

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/09/2022	SUPPL-26	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020148s026lbl.pdf
05/09/2022	SUPPL-26	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020148s026lbl.pdf
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

Therapeutic Equivalents for NDA 020148

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	HIKMA
DIHYDROERGOTAMINE MESYLATE	DIHYDROERGOTAMINE MESYLATE	0.5MG/SPRAY	SPRAY, METERED;NASAL	Prescription	No	AB	216881	RUBICON
MIGRANAL	DIHYDROERGOTAMINE MESYLATE	0.5MG/SPRAY	SPRAY, METERED;NASAL	Prescription	Yes	AB	020148	BAUSCH

Top