Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091154
Company: TEVA PHARMS USA

Products on ANDA 091154

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AMLODIPINE AND OLMESARTAN MEDOXOMIL	AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL	EQ 5MG BASE;20MG	TABLET;ORAL	Discontinued	None	No	No
AMLODIPINE AND OLMESARTAN MEDOXOMIL	AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL	EQ 5MG BASE;40MG	TABLET;ORAL	Discontinued	None	No	No
AMLODIPINE AND OLMESARTAN MEDOXOMIL	AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL	EQ 10MG BASE;20MG	TABLET;ORAL	Discontinued	None	No	No
AMLODIPINE AND OLMESARTAN MEDOXOMIL	AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL	EQ 10MG BASE;40MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091154

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/26/2016	ORIG-1	Approval			Letter (PDF) Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/091154Orig1s000TAltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/091154Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/24/2019	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
10/24/2019	SUPPL-2	Labeling-Package Insert		Label is not available on this site.