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. Thirty-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 |
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: | RLD: | Yes | |||||
Regulatory Exclusivity Expiration: | Jul 16, 2028 | ||||||||
Regulatory Exclusivity Use: | FOR PROPHYLAXIS OF ORGAN REJECTION IN ADULT AND PEDIATRIC PATIENTS RECEIVING ALLOGENEIC LUNG TRANSPLANT | ||||||||
Regulatory Exclusivity Expiration: | May 24, 2025 | ||||||||
Regulatory Exclusivity Use: | PROPHYLAXIS OF ORGAN REJECTION IN PEDIATRIC PATIENTS RECEIVING ALLOGENEIC KIDNEY OR HEART TRANSPLANTS, IN COMBINATION WITH OTHER IMMUNOSUPPRESSANTS |
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 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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