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Details for New Drug Application (NDA): 050709
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NDA 050709 describes PROGRAF, which is a drug marketed by Astellas and is included in three NDAs. Additional details are available on the PROGRAF profile page.
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.
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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