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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208206
Company: AMNEAL PHARMS

Products on ANDA 208206

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RALOXIFENE HYDROCHLORIDE	RALOXIFENE HYDROCHLORIDE	60MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 208206

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/08/2016	ORIG-1	Approval		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
10/11/2022	SUPPL-10	Labeling-Package Insert, Labeling-Medication Guide, Labeling-Container/Carton Labels		Label is not available on this site.
08/23/2019	SUPPL-2	Labeling-Package Insert, Labeling-Medication Guide, Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 208206

RALOXIFENE HYDROCHLORIDE

TABLET;ORAL; 60MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
EVISTA	RALOXIFENE HYDROCHLORIDE	60MG	TABLET;ORAL	Prescription	Yes	AB	020815	LILLY
RALOXIFENE HYDROCHLORIDE	RALOXIFENE HYDROCHLORIDE	60MG	TABLET;ORAL	Prescription	No	AB	208206	AMNEAL PHARMS
RALOXIFENE HYDROCHLORIDE	RALOXIFENE HYDROCHLORIDE	60MG	TABLET;ORAL	Prescription	No	AB	204310	AUROBINDO PHARMA
RALOXIFENE HYDROCHLORIDE	RALOXIFENE HYDROCHLORIDE	60MG	TABLET;ORAL	Prescription	No	AB	211324	CADILA PHARMS LTD
RALOXIFENE HYDROCHLORIDE	RALOXIFENE HYDROCHLORIDE	60MG	TABLET;ORAL	Prescription	No	AB	204491	GLENMARK PHARMS LTD
RALOXIFENE HYDROCHLORIDE	RALOXIFENE HYDROCHLORIDE	60MG	TABLET;ORAL	Prescription	No	AB	090842	INVAGEN PHARMS
RALOXIFENE HYDROCHLORIDE	RALOXIFENE HYDROCHLORIDE	60MG	TABLET;ORAL	Prescription	No	AB	206384	SCIEGEN PHARMS
RALOXIFENE HYDROCHLORIDE	RALOXIFENE HYDROCHLORIDE	60MG	TABLET;ORAL	Prescription	No	AB	078193	TEVA PHARMS USA
RALOXIFENE HYDROCHLORIDE	RALOXIFENE HYDROCHLORIDE	60MG	TABLET;ORAL	Prescription	No	AB	200825	WATSON LABS INC

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