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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 205003
Company: ADHERA

Products on NDA 205003

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PRESTALIA	AMLODIPINE BESYLATE; PERINDOPRIL ARGININE	EQ 2.5MG BASE;3.5MG	TABLET;ORAL	Prescription	None	Yes	No
PRESTALIA	AMLODIPINE BESYLATE; PERINDOPRIL ARGININE	EQ 5MG BASE;7MG	TABLET;ORAL	Prescription	None	Yes	No
PRESTALIA	AMLODIPINE BESYLATE; PERINDOPRIL ARGININE	EQ 10MG BASE;14MG	TABLET;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 205003

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/21/2015	ORIG-1	Approval	Type 4 - New Combination	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205003s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205003Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/205003Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/29/2017	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205003s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205003Orig1s003ltr.pdf
11/23/2016	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205003Ss002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205003Orig1s002ltr.pdf
08/25/2015	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205003s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205003Orig1s001ltr.pdf

Labels for NDA 205003

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/29/2017	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205003s003lbl.pdf
11/23/2016	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205003Ss002lbl.pdf
08/25/2015	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205003s001lbl.pdf
01/21/2015	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205003s000lbl.pdf

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