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): 020865
Company: ORGANON

Other Important Information from FDA

Products on NDA 020865

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MAXALT-MLT	RIZATRIPTAN BENZOATE	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING;ORAL	Discontinued	None	Yes	No
MAXALT-MLT	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020865

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/29/1998	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20864lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20864ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20864-20865.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/01/2019	SUPPL-24	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020864s023,020865s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020864Orig1s023, 020865Orig1s024ltr.pdf
05/29/2014	SUPPL-22	Manufacturing (CMC)		Label is not available on this site.
12/16/2011	SUPPL-21	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020864s011s016s017s018s019,020865s012s016s018s020s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020864s011,s016,s017,s018,s019,020865s012,s016,s018,s020,s021ltr.pdf
12/16/2011	SUPPL-20	Efficacy-Pediatric	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020864s011s016s017s018s019,020865s012s016s018s020s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020864s011,s016,s017,s018,s019,020865s012,s016,s018,s020,s021ltr.pdf
12/16/2011	SUPPL-18	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020864s011s016s017s018s019,020865s012s016s018s020s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020864s011,s016,s017,s018,s019,020865s012,s016,s018,s020,s021ltr.pdf
12/16/2011	SUPPL-16	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020864s011s016s017s018s019,020865s012s016s018s020s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020864s011,s016,s017,s018,s019,020865s012,s016,s018,s020,s021ltr.pdf
08/12/2010	SUPPL-14	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020865s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020865s014ltr.pdf
12/16/2011	SUPPL-12	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020864s011s016s017s018s019,020865s012s016s018s020s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020864s011,s016,s017,s018,s019,020865s012,s016,s018,s020,s021ltr.pdf
12/06/2001	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
04/22/2002	SUPPL-9	Labeling	Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20864s008.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020865_s009_MAXALT_TABLETS.pdf
03/23/2001	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
12/11/2000	SUPPL-7	Labeling	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20865S-007.pdf
12/11/2000	SUPPL-6	Efficacy-Labeling Change With Clinical Data	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20865S-006.pdf
12/11/2000	SUPPL-5	Labeling	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20865S-005.pdf
06/21/2000	SUPPL-4	Efficacy-Labeling Change With Clinical Data	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-864S004_review.pdf
03/28/2000	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
06/21/2000	SUPPL-2		Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-865S002_review.pdf
11/16/1999	SUPPL-1	Efficacy-Labeling Change With Clinical Data	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20865S1LTR.PDF

Labels for NDA 020865

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/01/2019	SUPPL-24	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020864s023,020865s024lbl.pdf
10/01/2019	SUPPL-24	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020864s023,020865s024lbl.pdf
12/16/2011	SUPPL-21	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020864s011s016s017s018s019,020865s012s016s018s020s021lbl.pdf
12/16/2011	SUPPL-20	Efficacy-Pediatric	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020864s011s016s017s018s019,020865s012s016s018s020s021lbl.pdf
12/16/2011	SUPPL-18	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020864s011s016s017s018s019,020865s012s016s018s020s021lbl.pdf
12/16/2011	SUPPL-16	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020864s011s016s017s018s019,020865s012s016s018s020s021lbl.pdf
12/16/2011	SUPPL-12	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020864s011s016s017s018s019,020865s012s016s018s020s021lbl.pdf
08/12/2010	SUPPL-14	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020865s014lbl.pdf
06/29/1998	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20864lbl.pdf

Therapeutic Equivalents for NDA 020865

MAXALT-MLT

TABLET, ORALLY DISINTEGRATING;ORAL; EQ 10MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MAXALT-MLT	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING;ORAL	Prescription	Yes	AB	020865	ORGANON
RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING;ORAL	Prescription	No	AB	203062	AUROBINDO PHARMA LTD
RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING;ORAL	Prescription	No	AB	203146	MACLEODS PHARMS LTD
RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING;ORAL	Prescription	No	AB	204722	PANACEA

Top