Details for New Drug Application (NDA): 206318
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NDA 206318 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 thirty-two drug master file entries for this compound. Twelve 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. Twelve suppliers are listed for this compound. Additional details are available on the rivastigmine tartrate profile page.
Summary for 206318
| Tradename: | RIVASTIGMINE |
| Applicant: | Zydus Pharms |
| Ingredient: | rivastigmine |
| Patents: | 0 |
Pharmacology for NDA: 206318
| Mechanism of Action | Cholinesterase Inhibitors |
Medical Subject Heading (MeSH) Categories for 206318
Suppliers and Packaging for NDA: 206318
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| RIVASTIGMINE | rivastigmine | FILM, EXTENDED RELEASE;TRANSDERMAL | 206318 | ANDA | Northstar Rx LLC. | 16714-115 | 16714-115-02 | 30 POUCH in 1 CARTON (16714-115-02) / 24 h in 1 POUCH (16714-115-01) |
| RIVASTIGMINE | rivastigmine | FILM, EXTENDED RELEASE;TRANSDERMAL | 206318 | ANDA | Northstar Rx LLC. | 16714-116 | 16714-116-02 | 30 POUCH in 1 CARTON (16714-116-02) / 24 h in 1 POUCH (16714-116-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FILM, EXTENDED RELEASE;TRANSDERMAL | Strength | 4.6MG/24HR | ||||
| Approval Date: | Mar 4, 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: | Mar 4, 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: | Mar 4, 2019 | TE: | AB | RLD: | No | ||||
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