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Drugs@FDA: FDA-Approved Drugs

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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.html

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 RESEARCH
DIHYDROERGOTAMINE MESYLATE	DIHYDROERGOTAMINE MESYLATE	0.5MG/SPRAY	SPRAY, METERED;NASAL	Prescription	No	AB	215228	SOMERSET THERAPS LLC
MIGRANAL	DIHYDROERGOTAMINE MESYLATE	0.5MG/SPRAY	SPRAY, METERED;NASAL	Prescription	Yes	AB	020148	BAUSCH

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