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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019815
Company: TAKEDA PHARMS USA

Products on NDA 019815

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PROAMATINE	MIDODRINE HYDROCHLORIDE	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No
PROAMATINE	MIDODRINE HYDROCHLORIDE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No
PROAMATINE	MIDODRINE HYDROCHLORIDE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019815

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/06/1996	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019815Orig1s000rev.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/07/2017	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019815s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019815Orig1s010ltr.pdf
07/22/2004	SUPPL-7	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19815s007ltr.pdf
02/22/2002	SUPPL-6	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
03/20/2002	SUPPL-5	Manufacturing (CMC)	Letter (PDF) Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19815s5ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/19-815s005_Midodrine.cfm
05/24/2000	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
01/28/1999	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
01/29/1999	SUPPL-2	Manufacturing (CMC)-Packaging		Label is not available on this site.
05/16/1997	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 019815

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/07/2017	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019815s010lbl.pdf

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