Details for New Drug Application (NDA): 204403
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NDA 204403 describes RIVASTIGMINE, which is a drug marketed by Alvogen, Amneal Pharms, Breckenridge, Mylan Technologies, 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 fifteen NDAs. It is available from nine suppliers. Additional details are available on the RIVASTIGMINE profile page.
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.
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 204403
| Tradename: | RIVASTIGMINE |
| Applicant: | Alvogen |
| Ingredient: | rivastigmine |
| Patents: | 0 |
Pharmacology for NDA: 204403
| Mechanism of Action | Cholinesterase Inhibitors |
Medical Subject Heading (MeSH) Categories for 204403
Suppliers and Packaging for NDA: 204403
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| RIVASTIGMINE | rivastigmine | FILM, EXTENDED RELEASE;TRANSDERMAL | 204403 | ANDA | Alvogen Inc. | 47781-304 | 47781-304-03 | 30 POUCH in 1 CARTON (47781-304-03) / 1 PATCH, EXTENDED RELEASE in 1 POUCH (47781-304-11) |
| RIVASTIGMINE | rivastigmine | FILM, EXTENDED RELEASE;TRANSDERMAL | 204403 | ANDA | Alvogen Inc. | 47781-305 | 47781-305-03 | 30 POUCH in 1 CARTON (47781-305-03) / 1 PATCH, EXTENDED RELEASE in 1 POUCH (47781-305-11) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FILM, EXTENDED RELEASE;TRANSDERMAL | Strength | 4.6MG/24HR | ||||
| Approval Date: | Sep 3, 2015 | 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: | Sep 3, 2015 | 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: | Aug 31, 2015 | TE: | AB | RLD: | No | ||||
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