Details for New Drug Application (NDA): 077169
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NDA 077169 describes ISRADIPINE, which is a drug marketed by Elite Labs Inc, Watson Labs Teva, and Norvium Bioscience, and is included in three NDAs. It is available from four suppliers. Additional details are available on the ISRADIPINE profile page.
The generic ingredient in ISRADIPINE is isradipine. There are seven drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the isradipine profile page.
The generic ingredient in ISRADIPINE is isradipine. There are seven drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the isradipine profile page.
Summary for 077169
| Tradename: | ISRADIPINE |
| Applicant: | Elite Labs Inc |
| Ingredient: | isradipine |
| Patents: | 0 |
Pharmacology for NDA: 077169
| Mechanism of Action | Calcium Channel Antagonists |
Medical Subject Heading (MeSH) Categories for 077169
Suppliers and Packaging for NDA: 077169
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ISRADIPINE | isradipine | CAPSULE;ORAL | 077169 | ANDA | Epic Pharma, LLC | 42806-263 | 42806-263-01 | 100 CAPSULE in 1 BOTTLE (42806-263-01) |
| ISRADIPINE | isradipine | CAPSULE;ORAL | 077169 | ANDA | Epic Pharma, LLC | 42806-263 | 42806-263-05 | 500 CAPSULE in 1 BOTTLE (42806-263-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 2.5MG | ||||
| Approval Date: | Apr 24, 2006 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 5MG | ||||
| Approval Date: | Apr 24, 2006 | TE: | AB | RLD: | No | ||||
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