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Details for New Drug Application (NDA): 050709
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The generic ingredient in PROGRAF is tacrolimus. There are twenty drug master file entries for this compound. Additional details are available on the tacrolimus profile page.
Summary for 050709
Tradename: | PROGRAF |
Applicant: | Astellas |
Ingredient: | tacrolimus |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 050709
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 5MG BASE/ML | ||||
Approval Date: | Apr 8, 1994 | TE: | AP | RLD: | Yes | ||||
Regulatory Exclusivity Expiration: | May 24, 2025 | ||||||||
Regulatory Exclusivity Use: |
Expired US Patents for NDA 050709
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Astellas | PROGRAF | tacrolimus | INJECTABLE;INJECTION | 050709-001 | Apr 8, 1994 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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