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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018200
Company: PADAGIS US

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MIDAMOR AMILORIDE HYDROCHLORIDE 5MG TABLET;ORAL Prescription AB 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
10/05/1981 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/25/2003 SUPPL-26 Labeling Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18200slr026,18201slr040ltr.pdf
06/24/2002 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.
03/21/2002 SUPPL-24 Labeling Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/18-200S024_Midamor_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18200s24ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/18-200s024_Midamor.cfm
09/18/2001 SUPPL-23 Labeling

Label is not available on this site.
11/21/2000 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.
02/12/1998 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.
09/16/1992 SUPPL-20 Labeling

Label is not available on this site.
03/26/1992 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.
05/14/1991 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.
04/12/1989 SUPPL-17 Labeling

Label is not available on this site.
03/29/1988 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.
06/01/1987 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.
03/09/1987 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.
06/22/1988 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.
01/21/1986 SUPPL-12 Labeling

Label is not available on this site.
11/01/1985 SUPPL-11 Labeling

Label is not available on this site.
05/05/1988 SUPPL-10 Labeling

Label is not available on this site.
09/10/1985 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.
06/14/1985 SUPPL-8 Labeling

Label is not available on this site.
02/07/1985 SUPPL-7 Labeling

Label is not available on this site.
01/04/1984 SUPPL-6 Manufacturing (CMC)-Formulation

Label is not available on this site.
12/23/1983 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.
03/01/1983 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.
07/08/1982 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.
03/03/1982 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.
02/08/1982 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
03/21/2002 SUPPL-24 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/18-200S024_Midamor_Prntlbl.pdf

MIDAMOR

TABLET;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMILORIDE HYDROCHLORIDE AMILORIDE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 070346 PAR PHARM
AMILORIDE HYDROCHLORIDE AMILORIDE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 079133 SIGMAPHARM LABS LLC
MIDAMOR AMILORIDE HYDROCHLORIDE 5MG TABLET;ORAL Prescription Yes AB 018200 PADAGIS US
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