Details for New Drug Application (NDA): 206651
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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 206651
| Tradename: | TACROLIMUS |
| Applicant: | Ajenat Pharms |
| Ingredient: | tacrolimus |
| Patents: | 0 |
Pharmacology for NDA: 206651
| Mechanism of Action | Calcineurin Inhibitors |
Medical Subject Heading (MeSH) Categories for 206651
Suppliers and Packaging for NDA: 206651
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TACROLIMUS | tacrolimus | CAPSULE;ORAL | 206651 | ANDA | BPI Labs LLC | 54288-133 | 54288-133-01 | 100 CAPSULE in 1 BOTTLE (54288-133-01) |
| TACROLIMUS | tacrolimus | CAPSULE;ORAL | 206651 | ANDA | BPI Labs LLC | 54288-134 | 54288-134-01 | 100 CAPSULE in 1 BOTTLE (54288-134-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 0.5MG BASE | ||||
| Approval Date: | Nov 30, 2017 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 1MG BASE | ||||
| Approval Date: | Nov 30, 2017 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 5MG BASE | ||||
| Approval Date: | Nov 30, 2017 | TE: | AB | RLD: | No | ||||
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