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Details for New Drug Application (NDA): 203340
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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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