Details for New Drug Application (NDA): 090509
✉ Email this page to a colleague
NDA 090509 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 090509
| Tradename: | TACROLIMUS |
| Applicant: | Dr Reddys Labs Ltd |
| Ingredient: | tacrolimus |
| Patents: | 0 |
Pharmacology for NDA: 090509
| Mechanism of Action | Calcineurin Inhibitors |
Medical Subject Heading (MeSH) Categories for 090509
Suppliers and Packaging for NDA: 090509
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TACROLIMUS | tacrolimus | CAPSULE;ORAL | 090509 | ANDA | Major Pharmaceuticals | 0904-6623 | 0904-6623-61 | 100 BLISTER PACK in 1 CARTON (0904-6623-61) / 1 CAPSULE in 1 BLISTER PACK |
| TACROLIMUS | tacrolimus | CAPSULE;ORAL | 090509 | ANDA | Major Pharmaceuticals | 0904-6624 | 0904-6624-61 | 100 BLISTER PACK in 1 CARTON (0904-6624-61) / 1 CAPSULE in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 0.5MG BASE | ||||
| Approval Date: | May 12, 2010 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 1MG BASE | ||||
| Approval Date: | May 12, 2010 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 5MG BASE | ||||
| Approval Date: | May 12, 2010 | TE: | AB | RLD: | No | ||||
Complete Access Available with Subscription
