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Details for New Drug Application (NDA): 203340
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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. There are four 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. Eight 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. Eight 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: | 4 |
| Formulation / Manufacturing: | see details |
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 | 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: | DISCN | Dosage: | SOLUTION;ORAL | Strength | 3MG/ML | ||||
| Approval Date: | May 10, 2013 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | May 10, 2020 | ||||||||
| Regulatory Exclusivity Use: | |||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 6MG/ML | ||||
| Approval Date: | Apr 8, 2020 | TE: | RLD: | Yes | |||||
| Patent: | Start Trial | Patent Expiration: | Apr 16, 2038 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | Start Trial | Patent Expiration: | Apr 16, 2038 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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