Details for New Drug Application (NDA): 201578
NDA 201578 describes SIROLIMUS, which is a drug marketed by Amneal, Apotex, Hetero Labs Ltd V, MSN, Novitium Pharma, Rising, Torrent, Alkem Labs Ltd, Dr Reddys, Glenmark Pharms Ltd, and Zydus Pharms, and is included in eleven NDAs. It is available from seventeen suppliers. Additional details are available on the SIROLIMUS profile page.
The generic ingredient in SIROLIMUS is sirolimus. There is one drug master file entry for this compound. Twenty suppliers are listed for this compound. Additional details are available on the sirolimus profile page.
The generic ingredient in SIROLIMUS is sirolimus. There is one drug master file entry for this compound. Twenty suppliers are listed for this compound. Additional details are available on the sirolimus profile page.
Pharmacology for NDA: 201578
| Mechanism of Action | Protein Kinase Inhibitors mTOR Inhibitors |
| Physiological Effect | Decreased Immunologic Activity |
Medical Subject Heading (MeSH) Categories for 201578
Suppliers and Packaging for NDA: 201578
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SIROLIMUS | sirolimus | TABLET;ORAL | 201578 | ANDA | AvPAK | 50268-718 | 50268-718-13 | 30 BLISTER PACK in 1 BOX (50268-718-13) / 1 TABLET in 1 BLISTER PACK (50268-718-11) |
| SIROLIMUS | sirolimus | TABLET;ORAL | 201578 | ANDA | Dr. Reddy's Laboratories Limited | 55111-653 | 55111-653-01 | 100 TABLET in 1 BOTTLE (55111-653-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1MG | ||||
| Approval Date: | Oct 27, 2014 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2MG | ||||
| Approval Date: | Oct 27, 2014 | TE: | AB | RLD: | No | ||||
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