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Drugs@FDA: FDA-Approved Drugs

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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MAXALT-MLT	RIZATRIPTAN BENZOATE	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING;ORAL	Discontinued	None	Yes	No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.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/01/2019	SUPPL-24	Labeling-Patient Package Insert, Labeling-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-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020864s023,020865s024lbl.pdf
10/01/2019	SUPPL-24	Labeling-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	201914	GLENMARK PHARMS 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	203478	NATCO PHARMA LTD
RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING;ORAL	Prescription	No	AB	204722	PANACEA

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