Details for New Drug Application (NDA): 065461
✉ Email this page to a colleague
NDA 065461 describes TACROLIMUS, which is a drug marketed by Chengdu, Accord Hlthcare, Ajenat Pharms, Alkem Labs Ltd, Biocon Pharma, Concord Biotech Ltd, Dr Reddys Labs Ltd, Glenmark Pharms Ltd, Hangzhou Zhongmei, Heritage Pharma Avet, Mylan, Panacea, Sandoz, Strides Pharma, Hospira, Nexus, Encube, and Fougera Pharms Inc, and is included in twenty NDAs. It is available from thirty-three suppliers. Additional details are available on the TACROLIMUS profile page.
The generic ingredient in TACROLIMUS is tacrolimus. There are twenty drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the tacrolimus profile page.
The generic ingredient in TACROLIMUS is tacrolimus. There are twenty drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the tacrolimus profile page.
Summary for 065461
| Tradename: | TACROLIMUS |
| Applicant: | Sandoz |
| Ingredient: | tacrolimus |
| Patents: | 0 |
Pharmacology for NDA: 065461
| Mechanism of Action | Calcineurin Inhibitors |
Medical Subject Heading (MeSH) Categories for 065461
Suppliers and Packaging for NDA: 065461
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TACROLIMUS | tacrolimus | CAPSULE;ORAL | 065461 | ANDA | Sandoz Inc. | 0781-2102 | 0781-2102-01 | 100 CAPSULE in 1 BOTTLE (0781-2102-01) |
| TACROLIMUS | tacrolimus | CAPSULE;ORAL | 065461 | ANDA | Sandoz Inc. | 0781-2103 | 0781-2103-01 | 100 CAPSULE in 1 BOTTLE (0781-2103-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 0.5MG BASE | ||||
| Approval Date: | Aug 10, 2009 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 1MG BASE | ||||
| Approval Date: | Aug 10, 2009 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 5MG BASE | ||||
| Approval Date: | Aug 10, 2009 | TE: | AB | RLD: | No | ||||
Complete Access Available with Subscription
