Details for New Drug Application (NDA): 207308
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The generic ingredient in RIVASTIGMINE is rivastigmine tartrate. There are thirty-two drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the rivastigmine tartrate profile page.
Summary for 207308
Tradename: | RIVASTIGMINE |
Applicant: | Amneal Pharms |
Ingredient: | rivastigmine |
Patents: | 0 |
Pharmacology for NDA: 207308
Mechanism of Action | Cholinesterase Inhibitors |
Medical Subject Heading (MeSH) Categories for 207308
Suppliers and Packaging for NDA: 207308
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
RIVASTIGMINE | rivastigmine | FILM, EXTENDED RELEASE;TRANSDERMAL | 207308 | ANDA | Amneal Pharmaceuticals LLC | 65162-749 | 65162-749-34 | 30 PATCH in 1 CARTON (65162-749-34) / 24 h in 1 PATCH |
RIVASTIGMINE | rivastigmine | FILM, EXTENDED RELEASE;TRANSDERMAL | 207308 | ANDA | Amneal Pharmaceuticals LLC | 65162-825 | 65162-825-34 | 30 PATCH in 1 CARTON (65162-825-34) / 24 h in 1 PATCH |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | FILM, EXTENDED RELEASE;TRANSDERMAL | Strength | 4.6MG/24HR | ||||
Approval Date: | Jan 8, 2019 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | FILM, EXTENDED RELEASE;TRANSDERMAL | Strength | 9.5MG/24HR | ||||
Approval Date: | Jan 8, 2019 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | FILM, EXTENDED RELEASE;TRANSDERMAL | Strength | 13.3MG/24HR | ||||
Approval Date: | Jan 8, 2019 | TE: | AB | RLD: | No |
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