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FDA Approval

Sirolimus

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
January 16, 2024
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Sirolimus(1 mg in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

American Health Packaging

American Health Packaging

929561009

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Sirolimus

Product Details

NDC Product Code
68084-915
Application Number
ANDA201578
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
January 16, 2024
CARNAUBA WAXInactive
Code: R12CBM0EIZClass: IACT
ETHYLCELLULOSE, UNSPECIFIEDInactive
Code: 7Z8S9VYZ4BClass: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
POLOXAMER 188Inactive
Code: LQA7B6G8JGClass: IACT
POLYETHYLENE GLYCOL 20000Inactive
Code: 5WKN5KL2O8Class: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3BClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
DIACETYLATED MONOGLYCERIDESInactive
Code: 5Z17386USFClass: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94EClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
AMMONIAInactive
Code: 5138Q19F1XClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
.ALPHA.-TOCOPHEROLInactive
Code: H4N855PNZ1Class: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
SirolimusActive
Code: W36ZG6FT64Class: ACTIBQuantity: 1 mg in 1 1
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