Details for New Drug Application (NDA): 076740
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NDA 076740 describes NIMODIPINE, which is a drug marketed by Bionpharma, Heritage Pharms, Sofgen Pharms, Sun Pharm Inds Inc, and Thepharmanetwork Llc, and is included in five NDAs. It is available from three suppliers. Additional details are available on the NIMODIPINE profile page.
The generic ingredient in NIMODIPINE is nimodipine. There are eight drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the nimodipine profile page.
The generic ingredient in NIMODIPINE is nimodipine. There are eight drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the nimodipine profile page.
Summary for 076740
| Tradename: | NIMODIPINE |
| Applicant: | Bionpharma |
| Ingredient: | nimodipine |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 076740
| Mechanism of Action | Calcium Channel Antagonists |
Medical Subject Heading (MeSH) Categories for 076740
Suppliers and Packaging for NDA: 076740
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NIMODIPINE | nimodipine | CAPSULE;ORAL | 076740 | ANDA | BIONPHARMA INC. | 69452-209 | 69452-209-13 | 3 BLISTER PACK in 1 CARTON (69452-209-13) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK |
| NIMODIPINE | nimodipine | CAPSULE;ORAL | 076740 | ANDA | BIONPHARMA INC. | 69452-209 | 69452-209-20 | 10 BLISTER PACK in 1 CARTON (69452-209-20) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 30MG | ||||
| Approval Date: | Jan 17, 2008 | TE: | AB | RLD: | No | ||||
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