Details for New Drug Application (NDA): 205622
NDA 205622 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 205622
| Tradename: | RIVASTIGMINE |
| Applicant: | Mylan Technologies |
| Ingredient: | rivastigmine |
| Patents: | 0 |
Pharmacology for NDA: 205622
| Mechanism of Action | Cholinesterase Inhibitors |
Medical Subject Heading (MeSH) Categories for 205622
Suppliers and Packaging for NDA: 205622
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| RIVASTIGMINE | rivastigmine | FILM, EXTENDED RELEASE;TRANSDERMAL | 205622 | ANDA | Mylan Pharmaceuticals Inc. | 0378-9070 | 0378-9070-93 | 30 POUCH in 1 CARTON (0378-9070-93) / 1 PATCH in 1 POUCH (0378-9070-16) / 24 h in 1 PATCH |
| RIVASTIGMINE | rivastigmine | FILM, EXTENDED RELEASE;TRANSDERMAL | 205622 | ANDA | Mylan Pharmaceuticals Inc. | 0378-9071 | 0378-9071-93 | 30 POUCH in 1 CARTON (0378-9071-93) / 1 PATCH in 1 POUCH (0378-9071-16) / 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: | Jun 20, 2018 | 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: | Jun 20, 2018 | 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: | Jun 20, 2018 | TE: | AB | RLD: | No | ||||
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