Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019815
Company: SHIRE LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROAMATINE MIDODRINE HYDROCHLORIDE 2.5MG TABLET;ORAL Discontinued None Yes No
PROAMATINE MIDODRINE HYDROCHLORIDE 5MG TABLET;ORAL Discontinued None Yes No
PROAMATINE MIDODRINE HYDROCHLORIDE 10MG TABLET;ORAL Discontinued None Yes No
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.

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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