Details for New Drug Application (NDA): 090509
✉ Email this page to a colleague
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 090509
Tradename: | TACROLIMUS |
Applicant: | Dr Reddys Labs Ltd |
Ingredient: | tacrolimus |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 090509
Mechanism of Action | Calcineurin Inhibitors |
Medical Subject Heading (MeSH) Categories for 090509
Suppliers and Packaging for NDA: 090509
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TACROLIMUS | tacrolimus | CAPSULE;ORAL | 090509 | ANDA | Major Pharmaceuticals | 0904-6623 | 0904-6623-61 | 100 BLISTER PACK in 1 CARTON (0904-6623-61) / 1 CAPSULE in 1 BLISTER PACK |
TACROLIMUS | tacrolimus | CAPSULE;ORAL | 090509 | ANDA | Major Pharmaceuticals | 0904-6624 | 0904-6624-61 | 100 BLISTER PACK in 1 CARTON (0904-6624-61) / 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: | May 12, 2010 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 1MG BASE | ||||
Approval Date: | May 12, 2010 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 5MG BASE | ||||
Approval Date: | May 12, 2010 | TE: | AB | RLD: | No |
Complete Access Available with Subscription