Details for New Drug Application (NDA): 090802
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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 090802
Tradename: | TACROLIMUS |
Applicant: | Panacea |
Ingredient: | tacrolimus |
Patents: | 0 |
Pharmacology for NDA: 090802
Mechanism of Action | Calcineurin Inhibitors |
Medical Subject Heading (MeSH) Categories for 090802
Suppliers and Packaging for NDA: 090802
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TACROLIMUS | tacrolimus | CAPSULE;ORAL | 090802 | ANDA | Panacea Biotec Limited | 43817-421 | 43817-421-01 | 100 CAPSULE, GELATIN COATED in 1 BOTTLE (43817-421-01) |
TACROLIMUS | tacrolimus | CAPSULE;ORAL | 090802 | ANDA | Panacea Biotec Limited | 43817-422 | 43817-422-01 | 100 CAPSULE, GELATIN COATED in 1 BOTTLE (43817-422-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 0.5MG BASE | ||||
Approval Date: | Sep 28, 2012 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 1MG BASE | ||||
Approval Date: | Sep 28, 2012 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 5MG BASE | ||||
Approval Date: | Sep 28, 2012 | TE: | AB | RLD: | No |
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