Details for New Drug Application (NDA): 091195
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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 091195
Tradename: | TACROLIMUS |
Applicant: | Accord Hlthcare |
Ingredient: | tacrolimus |
Patents: | 0 |
Pharmacology for NDA: 091195
Mechanism of Action | Calcineurin Inhibitors |
Medical Subject Heading (MeSH) Categories for 091195
Suppliers and Packaging for NDA: 091195
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TACROLIMUS | tacrolimus | CAPSULE;ORAL | 091195 | ANDA | Accord Healthcare Inc. | 16729-041 | 16729-041-01 | 100 CAPSULE in 1 BOTTLE (16729-041-01) |
TACROLIMUS | tacrolimus | CAPSULE;ORAL | 091195 | ANDA | Accord Healthcare Inc. | 16729-042 | 16729-042-01 | 100 CAPSULE in 1 BOTTLE (16729-042-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 0.5MG BASE | ||||
Approval Date: | Aug 31, 2011 | TE: | BX | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 1MG BASE | ||||
Approval Date: | Aug 31, 2011 | TE: | BX | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 5MG BASE | ||||
Approval Date: | Aug 31, 2011 | TE: | BX | RLD: | No |
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