Details for New Drug Application (NDA): 214753
✉ Email this page to a colleague
The generic ingredient in SIROLIMUS is sirolimus. There are twenty-one drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the sirolimus profile page.
Summary for 214753
Tradename: | SIROLIMUS |
Applicant: | Alkem Labs Ltd |
Ingredient: | sirolimus |
Patents: | 0 |
Pharmacology for NDA: 214753
Mechanism of Action | Protein Kinase Inhibitors mTOR Inhibitors |
Physiological Effect | Decreased Immunologic Activity |
Medical Subject Heading (MeSH) Categories for 214753
Suppliers and Packaging for NDA: 214753
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
SIROLIMUS | sirolimus | TABLET;ORAL | 214753 | ANDA | Major Pharmaceuticals | 0904-7248 | 0904-7248-04 | 30 BLISTER PACK in 1 CARTON (0904-7248-04) / 1 TABLET in 1 BLISTER PACK |
SIROLIMUS | sirolimus | TABLET;ORAL | 214753 | ANDA | Ascend Laboratories, LLC | 67877-746 | 67877-746-01 | 100 TABLET in 1 BOTTLE (67877-746-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.5MG | ||||
Approval Date: | Mar 12, 2021 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1MG | ||||
Approval Date: | Mar 12, 2021 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2MG | ||||
Approval Date: | Mar 12, 2021 | TE: | AB | RLD: | No |
Complete Access Available with Subscription