Details for New Drug Application (NDA): 215012
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NDA 215012 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 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-four 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-four suppliers are listed for this compound. Additional details are available on the tacrolimus profile page.
Summary for 215012
| Tradename: | TACROLIMUS |
| Applicant: | Chengdu |
| Ingredient: | tacrolimus |
| Patents: | 0 |
Pharmacology for NDA: 215012
| Mechanism of Action | Calcineurin Inhibitors |
Medical Subject Heading (MeSH) Categories for 215012
Suppliers and Packaging for NDA: 215012
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TACROLIMUS | tacrolimus | CAPSULE, EXTENDED RELEASE;ORAL | 215012 | ANDA | Chengdu Suncadia Medicine Co., Ltd. | 71432-2001 | 71432-2001-1 | 1 BAG in 1 CARTON (71432-2001-1) / 5 BLISTER PACK in 1 BAG / 10 CAPSULE, COATED, EXTENDED RELEASE in 1 BLISTER PACK |
| TACROLIMUS | tacrolimus | CAPSULE, EXTENDED RELEASE;ORAL | 215012 | ANDA | Chengdu Suncadia Medicine Co., Ltd. | 71432-2002 | 71432-2002-1 | 1 BAG in 1 CARTON (71432-2002-1) / 5 BLISTER PACK in 1 BAG / 10 CAPSULE, COATED, EXTENDED RELEASE in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | EQ 0.5MG BASE | ||||
| Approval Date: | Jan 25, 2024 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | EQ 1MG BASE | ||||
| Approval Date: | Jan 25, 2024 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | EQ 5MG BASE | ||||
| Approval Date: | Jan 25, 2024 | TE: | AB | RLD: | No | ||||
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