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Details for New Drug Application (NDA): 203340
NDA 203340 describes NYMALIZE, which is a drug marketed by Arbor Pharms Llc and is included in one NDA. It is available from one supplier. Additional details are available on the NYMALIZE profile page.
The generic ingredient in NYMALIZE is nimodipine. There are seven drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the nimodipine profile page.
The generic ingredient in NYMALIZE is nimodipine. There are seven drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the nimodipine profile page.
Summary for 203340
| Tradename: | NYMALIZE |
| Applicant: | Arbor Pharms Llc |
| Ingredient: | nimodipine |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 203340
| Ingredient-type | Dihydropyridines |
| Mechanism of Action | Calcium Channel Antagonists |
Medical Subject Heading (MeSH) Categories for 203340
Suppliers and Packaging for NDA: 203340
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NYMALIZE | nimodipine | SOLUTION;ORAL | 203340 | NDA | Arbor Pharmaceuticals | 24338-200 | 24338-200-12 | 12 PACKAGE in 1 CARTON (24338-200-12) > 1 CUP, UNIT-DOSE in 1 PACKAGE (24338-200-20) > 20 mL in 1 CUP, UNIT-DOSE |
| NYMALIZE | nimodipine | SOLUTION;ORAL | 203340 | NDA | Arbor Pharmaceuticals | 24338-200 | 24338-200-16 | 473 mL in 1 BOTTLE (24338-200-16) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 60MG/20ML | ||||
| Approval Date: | May 10, 2013 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | May 10, 2020 | ||||||||
| Regulatory Exclusivity Use: | IMPROVEMENT OF NEUROLOGICAL OUTCOME BY REDUCING THE INCIDENCE AND SEVERITY OF ISCHEMIC DEFICITS IN ADULT PATIENTS WITH SUBARACHNOID HEMORRHAGE FROM RUPTURED INTRACRANIAL BERRY ANEURYSMS REGARDLESS OF THEIR POST-ICTUS NEUROLOGICAL CONDITION | ||||||||
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