Sirolimus
- Product NDC
- 70954-075
- 11-digit product format
- 709540075
- Labeler code
- 70954
- Product ID
- 70954-075_207aa9ba-2d4d-4e70-a4d8-688065ef92a9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sirolimus
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Novitium Pharma LLC
- Application
- ANDA211040
- Marketing category
- ANDA
- Marketing start
- 2019-05-21
- Marketing end
- 0000-00-00
- Substance
- SIROLIMUS
- Active strength
- 1 mg/mL
- Pharmacologic classes
- Decreased Immunologic Activity [PE],mTOR Inhibitor Immunosuppressant [EPC],mTOR Inhibitors [MoA],Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record