Details for New Drug Application (NDA): 090802
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NDA 090802 describes TACROLIMUS, which is a drug marketed by Chengdu, Accord Hlthcare, Alkem Labs Ltd, Belcher, Biocon Pharma, Concord Biotech Ltd, Dr Reddys Labs Ltd, Glenmark Pharms Ltd, Hangzhou Zhongmei, Heritage Pharma Avet, Mylan, Panacea, Sandoz, Strides Pharma, Hospira, Encube, and Fougera Pharms Inc, and is included in nineteen NDAs. It is available from thirty-one 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-five 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-five suppliers are listed for this compound. Additional details are available on the tacrolimus profile page.
Summary for 090802
| Tradename: | TACROLIMUS |
| Applicant: | Panacea |
| Ingredient: | tacrolimus |
| Patents: | 0 |
Pharmacology for NDA: 090802
| Mechanism of Action | Calcineurin Inhibitors |
Medical Subject Heading (MeSH) Categories for 090802
Suppliers and Packaging for NDA: 090802
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TACROLIMUS | tacrolimus | CAPSULE;ORAL | 090802 | ANDA | Panacea Biotec Limited | 43817-421 | 43817-421-01 | 100 CAPSULE, GELATIN COATED in 1 BOTTLE (43817-421-01) |
| TACROLIMUS | tacrolimus | CAPSULE;ORAL | 090802 | ANDA | Panacea Biotec Limited | 43817-422 | 43817-422-01 | 100 CAPSULE, GELATIN COATED in 1 BOTTLE (43817-422-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 0.5MG BASE | ||||
| Approval Date: | Sep 28, 2012 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 1MG BASE | ||||
| Approval Date: | Sep 28, 2012 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 5MG BASE | ||||
| Approval Date: | Sep 28, 2012 | TE: | AB | RLD: | No | ||||
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