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Details for New Drug Application (NDA): 050709
NDA 050709 describes PROGRAF, which is a drug marketed by Astellas and is included in three NDAs. It is available from three suppliers. 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. Twenty-four suppliers are listed 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. Twenty-four suppliers are listed 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 |
Pharmacology for NDA: 050709
| Mechanism of Action | Calcineurin Inhibitors |
Medical Subject Heading (MeSH) Categories for 050709
Suppliers and Packaging for NDA: 050709
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PROGRAF | tacrolimus | INJECTABLE;INJECTION | 050709 | NDA | Astellas Pharma US, Inc. | 0469-3016 | 0469-3016-01 | 10 AMPULE in 1 BOX (0469-3016-01) > 1 mL in 1 AMPULE |
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 | ||||
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 | ➤ Try a Free Trial | ➤ Try a Free Trial |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
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