Details for New Drug Application (NDA): 200465
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NDA 200465 describes AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM, which is a drug marketed by Apotex, Dr Reddys, Mylan, and Zydus Pharms, and is included in four NDAs. It is available from six suppliers. Additional details are available on the AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM profile page.
The generic ingredient in AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM is amlodipine besylate; atorvastatin calcium. There are fifty drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the amlodipine besylate; atorvastatin calcium profile page.
The generic ingredient in AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM is amlodipine besylate; atorvastatin calcium. There are fifty drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the amlodipine besylate; atorvastatin calcium profile page.
Summary for 200465
| Tradename: | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM |
| Applicant: | Mylan |
| Ingredient: | amlodipine besylate; atorvastatin calcium |
| Patents: | 0 |
Suppliers and Packaging for NDA: 200465
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | amlodipine besylate; atorvastatin calcium | TABLET;ORAL | 200465 | ANDA | Mylan Pharmaceuticals Inc. | 0378-4513 | 0378-4513-93 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4513-93) |
| AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | amlodipine besylate; atorvastatin calcium | TABLET;ORAL | 200465 | ANDA | Mylan Pharmaceuticals Inc. | 0378-4514 | 0378-4514-93 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4514-93) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 2.5MG BASE;EQ 10MG BASE | ||||
| Approval Date: | Nov 29, 2013 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 2.5MG BASE;EQ 20MG BASE | ||||
| Approval Date: | Nov 29, 2013 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 2.5MG BASE;EQ 40MG BASE | ||||
| Approval Date: | Nov 29, 2013 | TE: | RLD: | No | |||||
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