Details for New Drug Application (NDA): 091689
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NDA 091689 describes RIVASTIGMINE TARTRATE, which is a drug marketed by 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 ten NDAs. It is available from thirteen suppliers. Additional details are available on the RIVASTIGMINE TARTRATE profile page.
The generic ingredient in RIVASTIGMINE TARTRATE 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 TARTRATE 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 091689
| Tradename: | RIVASTIGMINE TARTRATE |
| Applicant: | Alembic Pharms Ltd |
| Ingredient: | rivastigmine tartrate |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 091689
| Mechanism of Action | Cholinesterase Inhibitors |
Suppliers and Packaging for NDA: 091689
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| RIVASTIGMINE TARTRATE | rivastigmine tartrate | CAPSULE;ORAL | 091689 | ANDA | Alembic Pharmaceuticals Limited | 46708-063 | 46708-063-10 | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (46708-063-10) / 10 CAPSULE in 1 BLISTER PACK (46708-063-11) |
| RIVASTIGMINE TARTRATE | rivastigmine tartrate | CAPSULE;ORAL | 091689 | ANDA | Alembic Pharmaceuticals Limited | 46708-063 | 46708-063-30 | 30 CAPSULE in 1 BOTTLE (46708-063-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 1.5MG BASE | ||||
| Approval Date: | Jun 12, 2012 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 3MG BASE | ||||
| Approval Date: | Jun 12, 2012 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 4.5MG BASE | ||||
| Approval Date: | Jun 12, 2012 | TE: | AB | RLD: | No | ||||
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