Details for New Drug Application (NDA): 091001
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NDA 091001 describes NISOLDIPINE, which is a drug marketed by Amta and Mylan and is included in three NDAs. It is available from one supplier. Additional details are available on the NISOLDIPINE profile page.
The generic ingredient in NISOLDIPINE is nisoldipine. There are eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the nisoldipine profile page.
The generic ingredient in NISOLDIPINE is nisoldipine. There are eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the nisoldipine profile page.
Summary for 091001
| Tradename: | NISOLDIPINE |
| Applicant: | Mylan |
| Ingredient: | nisoldipine |
| Patents: | 0 |
Pharmacology for NDA: 091001
| Mechanism of Action | Calcium Channel Antagonists |
| Physiological Effect | Decreased Blood Pressure |
Medical Subject Heading (MeSH) Categories for 091001
Suppliers and Packaging for NDA: 091001
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NISOLDIPINE | nisoldipine | TABLET, EXTENDED RELEASE;ORAL | 091001 | ANDA | Mylan Pharmaceuticals Inc. | 0378-2096 | 0378-2096-01 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-2096-01) |
| NISOLDIPINE | nisoldipine | TABLET, EXTENDED RELEASE;ORAL | 091001 | ANDA | Mylan Pharmaceuticals Inc. | 0378-2097 | 0378-2097-01 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-2097-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 8.5MG | ||||
| Approval Date: | Jan 26, 2011 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 17MG | ||||
| Approval Date: | Jan 26, 2011 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 25.5MG | ||||
| Approval Date: | Jan 26, 2011 | TE: | RLD: | No | |||||
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