Details for New Drug Application (NDA): 215012
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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 215012
Tradename: | TACROLIMUS |
Applicant: | Chengdu |
Ingredient: | tacrolimus |
Patents: | 0 |
Formulation / Manufacturing: | see details |
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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