Details for New Drug Application (NDA): 200895
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The generic ingredient in SIMVASTATIN is simvastatin. There are forty drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the simvastatin profile page.
Summary for 200895
Tradename: | SIMVASTATIN |
Applicant: | Hetero Labs Ltd Iii |
Ingredient: | simvastatin |
Patents: | 0 |
Pharmacology for NDA: 200895
Mechanism of Action | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
Medical Subject Heading (MeSH) Categories for 200895
Suppliers and Packaging for NDA: 200895
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
SIMVASTATIN | simvastatin | TABLET;ORAL | 200895 | ANDA | Camber Pharmaceuticals, Inc. | 31722-510 | 31722-510-01 | 100 TABLET, FILM COATED in 1 BOTTLE (31722-510-01) |
SIMVASTATIN | simvastatin | TABLET;ORAL | 200895 | ANDA | Camber Pharmaceuticals, Inc. | 31722-510 | 31722-510-10 | 1000 TABLET, FILM COATED in 1 BOTTLE (31722-510-10) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Nov 25, 2014 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Nov 25, 2014 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
Approval Date: | Nov 25, 2014 | TE: | AB | RLD: | No |
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