Details for New Drug Application (NDA): 090687
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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 090687
Tradename: | TACROLIMUS |
Applicant: | Strides Pharma |
Ingredient: | tacrolimus |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 090687
Mechanism of Action | Calcineurin Inhibitors |
Medical Subject Heading (MeSH) Categories for 090687
Suppliers and Packaging for NDA: 090687
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TACROLIMUS | tacrolimus | CAPSULE;ORAL | 090687 | ANDA | Major Pharmaceuticals | 0904-7097 | 0904-7097-61 | 100 BLISTER PACK in 1 CARTON (0904-7097-61) / 1 CAPSULE in 1 BLISTER PACK |
TACROLIMUS | tacrolimus | CAPSULE;ORAL | 090687 | ANDA | Cardinal Health 107, LLC | 55154-4168 | 55154-4168-0 | 10 BLISTER PACK in 1 BAG (55154-4168-0) / 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: | Jul 22, 2014 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 1MG BASE | ||||
Approval Date: | Jul 22, 2014 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 5MG BASE | ||||
Approval Date: | Jul 22, 2014 | TE: | AB | RLD: | No |
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