Drugs@FDA: FDA-Approved Drugs
Company: TEVA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LOVASTATIN | LOVASTATIN | 40MG | TABLET;ORAL | Prescription | AB | No | No |
LOVASTATIN | LOVASTATIN | 20MG | TABLET;ORAL | Prescription | AB | No | No |
LOVASTATIN | LOVASTATIN | 10MG | TABLET;ORAL | Prescription | AB | No | No |
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/2001/075551.PDF |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/25/2020 | SUPPL-29 | Labeling-Package Insert |
Label is not available on this site. |
||
09/25/2020 | SUPPL-28 | Labeling-Package Insert |
Label is not available on this site. |
||
11/02/2014 | SUPPL-24 | Labeling-Package Insert |
Label is not available on this site. |
||
01/29/2013 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
||
05/02/2012 | SUPPL-22 | Labeling-Package Insert |
Label is not available on this site. |
||
04/14/2009 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
10/05/2007 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
03/13/2006 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
03/02/2006 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
08/18/2005 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
08/18/2005 | SUPPL-2 | Labeling |
Label is not available on this site. |
LOVASTATIN
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 |
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; 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 |