Details for New Drug Application (NDA): 206406
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NDA 206406 describes ENVARSUS XR, which is a drug marketed by Veloxis Pharms Inc and is included in one NDA. It is available from one supplier. There are twenty-two patents protecting this drug. Additional details are available on the ENVARSUS XR profile page.
The generic ingredient in ENVARSUS XR is tacrolimus. There are twenty drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the tacrolimus profile page.
The generic ingredient in ENVARSUS XR is tacrolimus. There are twenty drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the tacrolimus profile page.
Summary for 206406
| Tradename: | ENVARSUS XR |
| Applicant: | Veloxis Pharms Inc |
| Ingredient: | tacrolimus |
| Patents: | 22 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 206406
| Mechanism of Action | Calcineurin Inhibitors |
Medical Subject Heading (MeSH) Categories for 206406
Suppliers and Packaging for NDA: 206406
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ENVARSUS XR | tacrolimus | TABLET, EXTENDED RELEASE;ORAL | 206406 | NDA | Veloxis Pharmaceuticals, Inc | 68992-3010 | 68992-3010-1 | 1 POUCH in 1 CARTON (68992-3010-1) / 1 BOTTLE in 1 POUCH / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE |
| ENVARSUS XR | tacrolimus | TABLET, EXTENDED RELEASE;ORAL | 206406 | NDA | Veloxis Pharmaceuticals, Inc | 68992-3010 | 68992-3010-3 | 1 POUCH in 1 CARTON (68992-3010-3) / 1 BOTTLE, PLASTIC in 1 POUCH / 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 0.75MG BASE | ||||
| Approval Date: | Jul 10, 2015 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | May 30, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Aug 30, 2024 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | PROPHYLAXIS OF ORGAN REJECTION IN DE NOVO TRANSPLANT PATIENT | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Aug 30, 2024 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | PROPHYLAXIS OF ORGAN REJECTION IN PATIENTS CONVERTED FROM TACROLIMUS IMMEDIATE-RELEASE FORMULATIONS | ||||||||
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