Details for New Drug Application (NDA): 214753
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NDA 214753 describes SIROLIMUS, which is a drug marketed by Amneal, Apotex, MSN, Novitium Pharma, Torrent, Alkem Labs Ltd, Dr Reddys, Glenmark Pharms Ltd, and Zydus Pharms, and is included in nine NDAs. It is available from fourteen suppliers. Additional details are available on the SIROLIMUS profile page.
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.
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 |
| Formulation / Manufacturing: | see details |
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 | ||||
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