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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 204824
Company: OTTER PHARMS

Products on NDA 204824

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OTREXUP	METHOTREXATE	10MG/0.4ML (10MG/0.4ML)	SOLUTION;SUBCUTANEOUS	Prescription	None	Yes	Yes
OTREXUP	METHOTREXATE	15MG/0.4ML (15MG/0.4ML)	SOLUTION;SUBCUTANEOUS	Prescription	None	Yes	Yes
OTREXUP	METHOTREXATE	20MG/0.4ML (20MG/0.4ML)	SOLUTION;SUBCUTANEOUS	Prescription	None	Yes	Yes
OTREXUP	METHOTREXATE	25MG/0.4ML (25MG/0.4ML)	SOLUTION;SUBCUTANEOUS	Prescription	None	Yes	Yes
OTREXUP	METHOTREXATE	7.5MG/0.4ML (7.5MG/0.4ML)	SOLUTION;SUBCUTANEOUS	Discontinued	None	Yes	No
OTREXUP	METHOTREXATE	12.5MG/0.4ML (12.5MG/0.4ML)	SOLUTION;SUBCUTANEOUS	Prescription	None	Yes	Yes
OTREXUP	METHOTREXATE	17.5MG/0.4ML (17.5MG/0.4ML)	SOLUTION;SUBCUTANEOUS	Prescription	None	Yes	Yes
OTREXUP	METHOTREXATE	22.5MG/0.4ML (22.5MG/0.4ML)	SOLUTION;SUBCUTANEOUS	Prescription	None	Yes	Yes
OTREXUP PFS	METHOTREXATE	10MG/0.4ML (10MG/0.4ML)	SOLUTION;SUBCUTANEOUS	Discontinued	None	Yes	No
OTREXUP PFS	METHOTREXATE	15MG/0.6ML (15MG/0.6ML)	SOLUTION;SUBCUTANEOUS	Discontinued	None	Yes	No
OTREXUP PFS	METHOTREXATE	17.5MG/0.7ML (17.5MG/0.7ML)	SOLUTION;SUBCUTANEOUS	Discontinued	None	Yes	No
OTREXUP PFS	METHOTREXATE	20MG/0.8ML (20MG/0.8ML)	SOLUTION;SUBCUTANEOUS	Discontinued	None	Yes	No
OTREXUP PFS	METHOTREXATE	22.5MG/0.9ML (22.5MG/0.9ML)	SOLUTION;SUBCUTANEOUS	Discontinued	None	Yes	No
OTREXUP PFS	METHOTREXATE	25MG/ML (25MG/ML)	SOLUTION;SUBCUTANEOUS	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 204824

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/11/2013	ORIG-2	Approval	Efficacy	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204824Orig2s000Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204824Orig1s000,204824Orig2s000_replace_ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204824Orig2s000TOC.cfm
10/11/2013	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204824Orig1s000Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204824Orig1s000,204824Orig2s000_replace_ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204824Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/26/2019	SUPPL-10	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204824s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/204824Orig1s010ltr.pdf
06/19/2019	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204824s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/204824Orig1s009ltr.pdf
03/15/2018	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204824s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/2018/204824Orig1s008ltr.pdf
05/31/2017	SUPPL-6	Manufacturing (CMC)-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204824s006lbl.pdf
01/11/2017	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
03/24/2016	SUPPL-4	Manufacturing (CMC)	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204824s004lbl.pdf
11/07/2014	SUPPL-3	Manufacturing (CMC)	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204824s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204824Orig1s003ltr.pdf
10/08/2014	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
10/07/2014	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 204824

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/26/2019	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204824s010lbl.pdf
12/26/2019	SUPPL-10	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204824s010lbl.pdf
06/19/2019	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204824s009lbl.pdf
03/15/2018	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204824s008lbl.pdf
05/31/2017	SUPPL-6	Manufacturing (CMC)-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204824s006lbl.pdf
03/24/2016	SUPPL-4	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204824s004lbl.pdf
11/07/2014	SUPPL-3	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204824s003lbl.pdf
10/11/2013	ORIG-2	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204824Orig2s000Lbl.pdf
10/11/2013	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204824Orig1s000Lbl.pdf

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