Details for New Drug Application (NDA): 207308
NDA 207308 describes RIVASTIGMINE, which is a drug marketed by Alvogen, Amneal Pharms, Breckenridge, Mylan Technologies, Yichang Humanwell, Zydus Pharms, Alembic Pharms Ltd, Apotex Inc, Aurobindo Pharma, Cadila Pharms Ltd, Chartwell Rx, Dr Reddys Labs Inc, Macleods Pharms Ltd, Orbion Pharms, Sun Pharm, and Watson Labs, and is included in sixteen NDAs. It is available from seven suppliers. Additional details are available on the RIVASTIGMINE profile page.
The generic ingredient in RIVASTIGMINE is rivastigmine tartrate. There are two drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the rivastigmine tartrate profile page.
The generic ingredient in RIVASTIGMINE is rivastigmine tartrate. There are two drug master file entries for this compound. Eleven 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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