Details for New Drug Application (NDA): 203340
✉ Email this page to a colleague
NDA 203340 describes NYMALIZE, which is a drug marketed by Azurity and is included in one NDA. It is available from one supplier. There are six patents protecting this drug. Additional details are available on the NYMALIZE profile page.
The generic ingredient in NYMALIZE 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 NYMALIZE 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 203340
| Tradename: | NYMALIZE |
| Applicant: | Azurity |
| Ingredient: | nimodipine |
| Patents: | 6 |
Pharmacology for NDA: 203340
| 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 | Azurity Pharmaceuticals, Inc. | 24338-230 | 24338-230-12 | 12 PACKAGE in 1 CARTON (24338-230-12) / 1 SYRINGE, PLASTIC in 1 PACKAGE (24338-230-05) / 5 mL in 1 SYRINGE, PLASTIC |
| NYMALIZE | nimodipine | SOLUTION;ORAL | 203340 | NDA | Azurity Pharmaceuticals, Inc. | 24338-230 | 24338-230-30 | 12 BLISTER PACK in 1 CARTON (24338-230-30) / 1 SYRINGE, PLASTIC in 1 BLISTER PACK (24338-230-15) / 5 mL in 1 SYRINGE, PLASTIC |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;ORAL | Strength | 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | May 10, 2013 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 6MG/ML | ||||
| Approval Date: | Apr 8, 2020 | TE: | AB | RLD: | Yes | ||||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Apr 16, 2038 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | A METHOD FOR THE IMPROVEMENT OF NEUROLOGICAL OUTCOME BY REDUCING THE INCIDENCE AND SEVERITY OF ISCHEMIC DEFICITS IN ADULT PATIENTS WITH SUBARACHNOID HEMORRHAGE (SAH) FROM RUPTURED INTRACRANIAL BERRY ANEURYSMS | ||||||||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Apr 16, 2038 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | A METHOD FOR THE IMPROVEMENT OF NEUROLOGICAL OUTCOME BY REDUCING THE INCIDENCE AND SEVERITY OF ISCHEMIC DEFICITS IN ADULT PATIENTS WITH SUBARACHNOID HEMORRHAGE (SAH) FROM RUPTURED INTRACRANIAL BERRY ANEURYSMS | ||||||||
Expired US Patents for NDA 203340
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Azurity | NYMALIZE | nimodipine | SOLUTION;ORAL | 203340-002 | Apr 8, 2020 | ⤷ Get Started Free | ⤷ Get Started Free |
| Azurity | NYMALIZE | nimodipine | SOLUTION;ORAL | 203340-002 | Apr 8, 2020 | ⤷ Get Started Free | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Complete Access Available with Subscription
