Details for New Drug Application (NDA): 203740
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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 203740
Tradename: | TACROLIMUS |
Applicant: | Alkem Labs Ltd |
Ingredient: | tacrolimus |
Patents: | 0 |
Formulation / Manufacturing: | see details |
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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