Simvastatin is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Aurobindo Pharma Limited. The primary component is Simvastatin.
Product ID | 65862-054_10928f6e-d9d3-4481-b9de-4d6ab584f6a8 |
NDC | 65862-054 |
Product Type | Human Prescription Drug |
Proprietary Name | Simvastatin |
Generic Name | Simvastatin |
Dosage Form | Tablet, Film Coated |
Route of Administration | ORAL |
Marketing Start Date | 2006-12-20 |
Marketing Category | ANDA / DRUG FOR FURTHER PROCESSING |
Application Number | ANDA077691 |
Labeler Name | Aurobindo Pharma Limited |
Substance Name | SIMVASTATIN |
Active Ingredient Strength | 80 mg/1 |
Pharm Classes | HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] |
NDC Exclude Flag | N |
Listing Certified Through | 2021-12-31 |
Marketing Start Date | 2006-12-20 |
NDC Exclude Flag | N |
Sample Package? | N |
Marketing Category | ANDA |
Application Number | ANDA077691 |
Product Type | HUMAN PRESCRIPTION DRUG |
Marketing Start Date | 2006-12-20 |
Marketing Category | ANDA |
Application Number | ANDA077691 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | EA |
Marketing Start Date | 2006-12-20 |
Marketing Category | ANDA |
Application Number | ANDA077691 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | EA |
Marketing Start Date | 2006-12-20 |
Marketing Category | ANDA |
Application Number | ANDA077691 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | EA |
Marketing Start Date | 2006-12-20 |
Marketing Category | ANDA |
Application Number | ANDA077691 |
Product Type | HUMAN PRESCRIPTION DRUG |
Marketing Start Date | 2006-12-20 |
Marketing Category | ANDA |
Application Number | ANDA077691 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | EA |
Marketing Start Date | 2006-12-20 |
Marketing Category | ANDA |
Application Number | ANDA077691 |
Product Type | HUMAN PRESCRIPTION DRUG |
Marketing Start Date | 2010-09-03 |
Marketing End Date | 2011-08-29 |
Ingredient | Strength |
---|---|
SIMVASTATIN | 80 mg/1 |
NDC | Brand Name | Generic Name |
---|---|---|
0093-7152 | Simvastatin | Simvastatin |
0093-7153 | Simvastatin | Simvastatin |
0093-7154 | Simvastatin | Simvastatin |
0093-7155 | Simvastatin | Simvastatin |
0093-7156 | Simvastatin | Simvastatin |
0179-0128 | Simvastatin | Simvastatin |
0179-0240 | simvastatin | simvastatin |
0179-0241 | simvastatin | simvastatin |
0179-0242 | simvastatin | simvastatin |
0179-0243 | simvastatin | simvastatin |
0179-1897 | Simvastatin | Simvastatin |
0179-1898 | Simvastatin | Simvastatin |
0179-1899 | Simvastatin | Simvastatin |
0615-6579 | Simvastatin | Simvastatin |
0615-6580 | Simvastatin | Simvastatin |
0615-6581 | Simvastatin | Simvastatin |
0615-6587 | Simvastatin | Simvastatin |
0615-6588 | Simvastatin | Simvastatin |
0615-7704 | Simvastatin | Simvastatin |
0615-7705 | Simvastatin | Simvastatin |
0615-7706 | Simvastatin | Simvastatin |
68071-1646 | simvastatin | simvastatin |
68071-1965 | simvastatin | simvastatin |
68071-1721 | simvastatin | simvastatin |
68071-1711 | simvastatin | simvastatin |
68071-2092 | Simvastatin | Simvastatin |
68071-1990 | simvastatin | simvastatin |
68071-1699 | simvastatin | simvastatin |
68071-1868 | simvastatin | simvastatin |
68071-1946 | simvastatin | simvastatin |
68071-3115 | Simvastatin | Simvastatin |
68071-3391 | simvastatin | simvastatin |
68071-3157 | Simvastatin | Simvastatin |
68071-3289 | simvastatin | simvastatin |
68071-4331 | SIMVASTATIN | SIMVASTATIN |
68071-4504 | simvastatin | simvastatin |
68084-512 | Simvastatin | Simvastatin |
68151-0177 | Simvastatin | Simvastatin |
68084-511 | Simvastatin | Simvastatin |
68180-481 | SIMVASTATIN | SIMVASTATIN |
68180-482 | SIMVASTATIN | SIMVASTATIN |
68180-465 | SIMVASTATIN | SIMVASTATIN |
68180-478 | SIMVASTATIN | SIMVASTATIN |
68180-480 | SIMVASTATIN | SIMVASTATIN |
68180-464 | SIMVASTATIN | SIMVASTATIN |
68180-479 | SIMVASTATIN | SIMVASTATIN |
68382-069 | Simvastatin | Simvastatin |
68382-067 | Simvastatin | Simvastatin |
68382-065 | Simvastatin | Simvastatin |
68382-068 | Simvastatin | Simvastatin |