Details for New Drug Application (NDA): 203740
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NDA 203740 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-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-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 203740
| Tradename: | TACROLIMUS |
| Applicant: | Alkem Labs Ltd |
| Ingredient: | tacrolimus |
| Patents: | 0 |
Pharmacology for NDA: 203740
| Mechanism of Action | Calcineurin Inhibitors |
Medical Subject Heading (MeSH) Categories for 203740
Suppliers and Packaging for NDA: 203740
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TACROLIMUS | tacrolimus | CAPSULE;ORAL | 203740 | ANDA | Ascend Laboratories, LLC | 67877-278 | 67877-278-01 | 100 CAPSULE in 1 BOTTLE (67877-278-01) |
| TACROLIMUS | tacrolimus | CAPSULE;ORAL | 203740 | ANDA | Ascend Laboratories, LLC | 67877-278 | 67877-278-33 | 50 BLISTER PACK in 1 CARTON (67877-278-33) / 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: | Nov 12, 2020 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 1MG BASE | ||||
| Approval Date: | Nov 12, 2020 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 5MG BASE | ||||
| Approval Date: | Nov 12, 2020 | TE: | AB | RLD: | No | ||||
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