Details for New Drug Application (NDA): 200744
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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 200744
Tradename: | TACROLIMUS |
Applicant: | Fougera Pharms Inc |
Ingredient: | tacrolimus |
Patents: | 0 |
Pharmacology for NDA: 200744
Mechanism of Action | Calcineurin Inhibitors |
Medical Subject Heading (MeSH) Categories for 200744
Suppliers and Packaging for NDA: 200744
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TACROLIMUS | tacrolimus | OINTMENT;TOPICAL | 200744 | ANDA | E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. | 0168-0416 | 0168-0416-30 | 1 TUBE in 1 CARTON (0168-0416-30) / 30 g in 1 TUBE |
TACROLIMUS | tacrolimus | OINTMENT;TOPICAL | 200744 | ANDA | E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. | 0168-0416 | 0168-0416-60 | 1 TUBE in 1 CARTON (0168-0416-60) / 60 g in 1 TUBE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | OINTMENT;TOPICAL | Strength | 0.03% | ||||
Approval Date: | Sep 9, 2014 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | OINTMENT;TOPICAL | Strength | 0.1% | ||||
Approval Date: | Sep 9, 2014 | TE: | AB | RLD: | No |
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