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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078193
Company: TEVA PHARMS USA

Products on ANDA 078193

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 078193

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/04/2014	ORIG-1	Approval			Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/078193Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/078193Orig1s000.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/09/2019	SUPPL-8	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/09/2019	SUPPL-5	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 078193

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 INC
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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