Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075828
Company: ACTAVIS ELIZABETH

Products on ANDA 075828

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LOVASTATIN	LOVASTATIN	10MG	TABLET;ORAL	Prescription	AB	No	No
LOVASTATIN	LOVASTATIN	20MG	TABLET;ORAL	Prescription	AB	No	No
LOVASTATIN	LOVASTATIN	40MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075828

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/17/2001	ORIG-1	Approval			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/075828.PDF

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/25/2020	SUPPL-39	Labeling-Package Insert		Label is not available on this site.
08/04/2017	SUPPL-36	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
11/02/2014	SUPPL-34	Labeling-Package Insert		Label is not available on this site.
12/29/2012	SUPPL-33	Labeling-Package Insert		Label is not available on this site.
03/26/2012	SUPPL-29	Labeling-Package Insert		Label is not available on this site.
09/09/2014	SUPPL-24	Labeling		Label is not available on this site.
02/05/2008	SUPPL-19	Labeling		Label is not available on this site.
02/09/2007	SUPPL-12	Labeling		Label is not available on this site.
06/06/2003	SUPPL-2	Labeling		Label is not available on this site.
07/22/2002	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Therapeutic Equivalents for ANDA 075828

LOVASTATIN

TABLET;ORAL; 10MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LOVASTATIN	LOVASTATIN	10MG	TABLET;ORAL	Prescription	No	AB	075828	ACTAVIS ELIZABETH
LOVASTATIN	LOVASTATIN	10MG	TABLET;ORAL	Prescription	No	AB	075991	CARLSBAD
LOVASTATIN	LOVASTATIN	10MG	TABLET;ORAL	Prescription	No	AB	075300	CHARTWELL RX
LOVASTATIN	LOVASTATIN	10MG	TABLET;ORAL	Prescription	No	AB	077748	COREPHARMA
LOVASTATIN	LOVASTATIN	10MG	TABLET;ORAL	Prescription	No	AB	075636	EPIC PHARMA LLC
LOVASTATIN	LOVASTATIN	10MG	TABLET;ORAL	Prescription	No	AB	078296	LUPIN
LOVASTATIN	LOVASTATIN	10MG	TABLET;ORAL	Prescription	No	AB	075551	TEVA

TABLET;ORAL; 20MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LOVASTATIN	LOVASTATIN	20MG	TABLET;ORAL	Prescription	No	AB	075828	ACTAVIS ELIZABETH
LOVASTATIN	LOVASTATIN	20MG	TABLET;ORAL	Prescription	No	AB	075991	CARLSBAD
LOVASTATIN	LOVASTATIN	20MG	TABLET;ORAL	Prescription	No	AB	075300	CHARTWELL RX
LOVASTATIN	LOVASTATIN	20MG	TABLET;ORAL	Prescription	No	AB	077748	COREPHARMA
LOVASTATIN	LOVASTATIN	20MG	TABLET;ORAL	Prescription	No	AB	075636	EPIC PHARMA LLC
LOVASTATIN	LOVASTATIN	20MG	TABLET;ORAL	Prescription	No	AB	078296	LUPIN
LOVASTATIN	LOVASTATIN	20MG	TABLET;ORAL	Prescription	No	AB	075551	TEVA

TABLET;ORAL; 40MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LOVASTATIN	LOVASTATIN	40MG	TABLET;ORAL	Prescription	No	AB	075828	ACTAVIS ELIZABETH
LOVASTATIN	LOVASTATIN	40MG	TABLET;ORAL	Prescription	No	AB	075991	CARLSBAD
LOVASTATIN	LOVASTATIN	40MG	TABLET;ORAL	Prescription	No	AB	075300	CHARTWELL RX
LOVASTATIN	LOVASTATIN	40MG	TABLET;ORAL	Prescription	No	AB	077748	COREPHARMA
LOVASTATIN	LOVASTATIN	40MG	TABLET;ORAL	Prescription	No	AB	075636	EPIC PHARMA LLC
LOVASTATIN	LOVASTATIN	40MG	TABLET;ORAL	Prescription	No	AB	078296	LUPIN
LOVASTATIN	LOVASTATIN	40MG	TABLET;ORAL	Prescription	No	AB	075551	TEVA