Details for New Drug Application (NDA): 077811
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NDA 077811 describes NIMODIPINE, which is a drug marketed by Bionpharma, Heritage, Sofgen Pharms, Sun Pharm Inds Inc, Thepharmanetwork Llc, and Annora Pharma, and is included in six 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 077811
| Tradename: | NIMODIPINE |
| Applicant: | Heritage |
| Ingredient: | nimodipine |
| Patents: | 0 |
Pharmacology for NDA: 077811
| Mechanism of Action | Calcium Channel Antagonists |
Medical Subject Heading (MeSH) Categories for 077811
Suppliers and Packaging for NDA: 077811
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NIMODIPINE | nimodipine | CAPSULE;ORAL | 077811 | ANDA | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-512 | 23155-512-00 | 10 BLISTER PACK in 1 CARTON (23155-512-00) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK |
| NIMODIPINE | nimodipine | CAPSULE;ORAL | 077811 | ANDA | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-512 | 23155-512-30 | 3 BLISTER PACK in 1 CARTON (23155-512-30) / 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: | May 2, 2007 | TE: | AB | RLD: | No | ||||
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