Details for New Drug Application (NDA): 208691
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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 208691
Tradename: | SIROLIMUS |
Applicant: | Glenmark Pharms Ltd |
Ingredient: | sirolimus |
Patents: | 0 |
Pharmacology for NDA: 208691
Mechanism of Action | Protein Kinase Inhibitors mTOR Inhibitors |
Physiological Effect | Decreased Immunologic Activity |
Medical Subject Heading (MeSH) Categories for 208691
Suppliers and Packaging for NDA: 208691
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
SIROLIMUS | sirolimus | TABLET;ORAL | 208691 | ANDA | NORTHSTAR RX LLC | 16714-187 | 16714-187-01 | 100 TABLET, FILM COATED in 1 BOTTLE (16714-187-01) |
SIROLIMUS | sirolimus | TABLET;ORAL | 208691 | ANDA | NORTHSTAR RX LLC | 16714-188 | 16714-188-01 | 100 TABLET, FILM COATED in 1 BOTTLE (16714-188-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.5MG | ||||
Approval Date: | Oct 16, 2020 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1MG | ||||
Approval Date: | Oct 16, 2020 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2MG | ||||
Approval Date: | Oct 16, 2020 | TE: | AB | RLD: | No |
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