sirolimus Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
immunosuppressants, rapamycin derivatives 2446 53123-88-9

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • sirolimus
  • rapamycin
  • rapammune
  • rapamune
  • supralimus
  • rapalimus
  • AY22989
  • AY-22989
A macrolide compound obtained from Streptomyces hygroscopicus that acts by selectively blocking the transcriptional activation of cytokines thereby inhibiting cytokine production. It is bioactive only when bound to IMMUNOPHILINS. Sirolimus is a potent immunosuppressant and possesses both antifungal and antineoplastic properties.
  • Molecular weight: 914.19
  • Formula: C51H79NO13
  • CLOGP: 7.04
  • LIPINSKI: 3
  • HAC: 14
  • HDO: 3
  • TPSA: 195.43
  • ALOGS: -5.72
  • ROTB: 6

  • Status: OFP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
3 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 2 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.15 ┬ÁM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 15 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Approvals:

DateAgencyCompanyOrphan
Sept. 15, 1999 FDA PF PRISM CV

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Transplant dysfunction 1721.99 44.72 231 1889 189 2355776
Transplant rejection 1681.50 44.72 258 1862 948 2355017
Ovarian cyst 1274.65 44.72 218 1902 1755 2354210
Acne 1138.94 44.72 213 1907 2963 2353002
Alopecia 841.93 44.72 238 1882 21763 2334202
Sleep disorder due to general medical condition, insomnia type 488.18 44.72 76 2044 297 2355668
Product use in unapproved indication 392.96 44.72 114 2006 11086 2344879
Pneumonia 354.35 44.72 154 1966 49142 2306823
Condition aggravated 317.39 44.72 126 1994 31853 2324112
Product use issue 310.56 44.72 97 2023 12072 2343893
Liver function test abnormal 261.05 44.72 76 2044 7414 2348551
Kidney transplant rejection 210.98 44.72 41 2079 676 2355289
Off label use 209.22 44.72 123 1997 73475 2282490
Rheumatoid arthritis 205.26 44.72 80 2040 19060 2336905
Loss of personal independence in daily activities 180.89 44.72 53 2067 5258 2350707
Thrombotic microangiopathy 179.70 44.72 40 2080 1307 2354658
Immunosuppressant drug level increased 172.65 44.72 32 2088 403 2355562
Diarrhoea 169.92 44.72 113 2007 83451 2272514
Pain 161.33 44.72 98 2022 61759 2294206
Pyrexia 158.00 44.72 92 2028 53616 2302349
Drug ineffective 154.44 44.72 115 2005 101509 2254456
Post transplant lymphoproliferative disorder 148.15 44.72 29 2091 496 2355469
Epstein-Barr virus infection 137.28 44.72 31 2089 1080 2354885
Renal impairment 136.22 44.72 50 2070 10042 2345923
Acute kidney injury 135.50 44.72 67 2053 28055 2327910
Blood creatinine increased 134.14 44.72 50 2070 10483 2345482
Anaemia 122.04 44.72 67 2053 34725 2321240
Graft versus host disease 114.36 44.72 26 2094 933 2355032
Cytomegalovirus infection 114.35 44.72 32 2088 2681 2353284
Chronic allograft nephropathy 113.94 44.72 19 2101 122 2355843
Pneumonitis 110.18 44.72 34 2086 4005 2351960
Liver transplant rejection 108.85 44.72 21 2099 331 2355634
Graft versus host disease in gastrointestinal tract 107.76 44.72 20 2100 253 2355712
Drug interaction 107.29 44.72 58 2062 29105 2326860
Human herpesvirus 6 infection 107.25 44.72 21 2099 359 2355606
Interstitial lung disease 106.44 44.72 39 2081 7773 2348192
Cryptosporidiosis infection 98.71 44.72 15 2105 47 2355918
Urinary tract infection 97.61 44.72 55 2065 29887 2326078
Pleural effusion 91.27 44.72 39 2081 11629 2344336
Renal failure 85.35 44.72 42 2078 17307 2338658
Toxicity to various agents 85.21 44.72 52 2068 32702 2323263
Pneumocystis jirovecii pneumonia 83.09 44.72 24 2096 2249 2353716
Lymphocele 83.07 44.72 15 2105 161 2355804
Graft versus host disease in skin 82.46 44.72 16 2104 260 2355705
Diabetes mellitus 82.42 44.72 32 2088 7463 2348502
Thrombocytopenia 81.46 44.72 42 2078 19089 2336876
Stomatitis 81.05 44.72 34 2086 9676 2346289
Pseudomonas infection 78.84 44.72 20 2100 1146 2354819
Complications of transplanted kidney 78.58 44.72 16 2104 336 2355629
Nephropathy toxic 78.47 44.72 20 2100 1168 2354797
Drug level increased 78.26 44.72 24 2096 2763 2353202
Dehydration 75.42 44.72 42 2078 22253 2333712
Proteinuria 73.52 44.72 23 2097 2827 2353138
Respiratory failure 73.28 44.72 35 2085 13493 2342472
Leukopenia 72.90 44.72 32 2088 10164 2345801
Squamous cell carcinoma 70.71 44.72 19 2101 1364 2354601
Multiple organ dysfunction syndrome 67.94 44.72 28 2092 7613 2348352
Vomiting 66.11 44.72 61 2059 71541 2284424
Kidney fibrosis 65.63 44.72 13 2107 236 2355729
Hypertriglyceridaemia 63.69 44.72 16 2104 880 2355085
Polyomavirus-associated nephropathy 62.80 44.72 12 2108 179 2355786
Adenovirus infection 61.71 44.72 13 2107 324 2355641
Haemodialysis 58.85 44.72 18 2102 2051 2353914
Haemoglobin decreased 58.10 44.72 33 2087 18118 2337847
Overdose 57.89 44.72 34 2086 19873 2336092
Epstein-Barr virus associated lymphoproliferative disorder 57.88 44.72 12 2108 276 2355689
General physical health deterioration 57.14 44.72 30 2090 14109 2341856
Pulmonary alveolar haemorrhage 56.74 44.72 14 2106 715 2355250
Septic shock 56.50 44.72 24 2096 7030 2348935
Adjusted calcium decreased 56.26 44.72 8 2112 13 2355952
Sepsis 54.87 44.72 32 2088 18456 2337509
Weight decreased 53.86 44.72 37 2083 28334 2327631
Skin squamous cell carcinoma metastatic 53.48 44.72 7 2113 3 2355962
Posterior reversible encephalopathy syndrome 51.59 44.72 17 2103 2463 2353502
Asthenia 49.16 44.72 43 2077 46883 2309082
Globulins decreased 49.01 44.72 8 2112 44 2355921
Nausea 48.20 44.72 64 2056 112125 2243840
Lymphopenia 47.77 44.72 16 2104 2438 2353527
Hypoalbuminaemia 47.74 44.72 14 2106 1380 2354585
Oedema peripheral 47.48 44.72 32 2088 23731 2332234
Focal segmental glomerulosclerosis 47.47 44.72 10 2110 249 2355716
Pericardial effusion 47.18 44.72 18 2102 3991 2351974
Dyspnoea 46.88 44.72 53 2067 78680 2277285
Chronic kidney disease 46.71 44.72 18 2102 4100 2351865
Kaposi's sarcoma 46.41 44.72 10 2110 278 2355687
Respiratory distress 46.26 44.72 19 2101 5110 2350855
Neutropenia 45.41 44.72 30 2090 21518 2334447
Death 45.41 44.72 53 2067 81415 2274550
Oedema 45.09 44.72 23 2097 10180 2345785
Immunosuppressant drug level decreased 44.99 44.72 9 2111 172 2355793

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Product use in unapproved indication 581.86 41.56 176 2553 9246 1734806
Kidney transplant rejection 426.44 41.56 91 2638 1103 1742949
Transplant rejection 398.37 41.56 88 2641 1266 1742786
Off label use 338.10 41.56 175 2554 38396 1705656
Product use issue 245.24 41.56 90 2639 8481 1735571
Pyrexia 223.93 41.56 143 2586 46257 1697795
Blood creatinine increased 215.80 41.56 94 2635 13852 1730200
Cytomegalovirus infection 195.47 41.56 60 2669 3241 1740811
Renal impairment 183.88 41.56 81 2648 12233 1731819
Interstitial lung disease 181.89 41.56 75 2654 9621 1734431
Pneumonia 175.85 41.56 123 2606 46059 1697993
Immunosuppressant drug level increased 166.02 41.56 37 2692 550 1743502
Acute kidney injury 163.83 41.56 106 2623 34838 1709214
Liver transplant rejection 162.92 41.56 35 2694 434 1743618
Lymphocele 149.01 41.56 28 2701 164 1743888
Proteinuria 136.24 41.56 44 2685 2800 1741252
Thrombotic microangiopathy 132.24 41.56 36 2693 1259 1742793
Complications of transplanted kidney 127.36 41.56 30 2699 576 1743476
Condition aggravated 126.34 41.56 75 2654 21075 1722977
Chronic allograft nephropathy 122.45 41.56 24 2705 181 1743871
Bronchopulmonary aspergillosis 121.01 41.56 35 2694 1531 1742521
Diarrhoea 120.76 41.56 105 2624 53747 1690305
Multiple organ dysfunction syndrome 116.20 41.56 54 2675 9188 1734864
Post transplant lymphoproliferative disorder 115.99 41.56 29 2700 721 1743331
Squamous cell carcinoma 110.60 41.56 34 2695 1837 1742215
Thrombocytopenia 105.52 41.56 67 2662 21182 1722870
Nephropathy toxic 104.60 41.56 32 2697 1700 1742352
Renal failure 104.11 41.56 65 2664 19952 1724100
Sepsis 100.77 41.56 63 2666 19375 1724677
Epstein-Barr virus infection 99.75 41.56 28 2701 1097 1742955
Kaposi's sarcoma 97.42 41.56 26 2703 841 1743211
Pneumonitis 93.10 41.56 36 2693 3879 1740173
Cough 91.46 41.56 59 2670 19138 1724914
BK virus infection 86.62 41.56 21 2708 457 1743595
Transplant dysfunction 86.25 41.56 20 2709 357 1743695
Adenovirus infection 82.24 41.56 20 2709 441 1743611
Anaemia 81.43 41.56 65 2664 29392 1714660
Pericardial effusion 79.97 41.56 31 2698 3359 1740693
Oedema peripheral 79.51 41.56 50 2679 15500 1728552
Renal tubular necrosis 78.38 41.56 27 2702 2092 1741960
Graft versus host disease 78.30 41.56 25 2704 1528 1742524
Cytomegalovirus viraemia 77.96 41.56 20 2709 552 1743500
Respiratory failure 77.59 41.56 48 2681 14457 1729595
Dyspnoea 77.31 41.56 81 2648 51978 1692074
Nocardiosis 74.35 41.56 19 2710 516 1743536
Brain abscess 72.25 41.56 18 2711 440 1743612
Dehydration 71.32 41.56 49 2680 17609 1726443
Death 70.84 41.56 100 2629 87343 1656709
Septic shock 70.83 41.56 37 2692 8072 1735980
Impaired healing 69.52 41.56 26 2703 2553 1741499
Deep vein thrombosis 69.22 41.56 39 2690 9881 1734171
Transplant failure 68.97 41.56 17 2712 397 1743655
Focal segmental glomerulosclerosis 68.09 41.56 16 2713 303 1743749
Toxicity to various agents 65.33 41.56 57 2672 29084 1714968
Candida infection 64.92 41.56 23 2706 1935 1742117
Diabetes mellitus 64.58 41.56 33 2696 6875 1737177
Squamous cell carcinoma of skin 62.63 41.56 20 2709 1222 1742830
Pleural effusion 62.52 41.56 38 2691 11072 1732980
Hyperlipidaemia 62.01 41.56 23 2706 2206 1741846
Cellulitis 60.75 41.56 31 2698 6437 1737615
Kidney fibrosis 60.38 41.56 15 2714 362 1743690
Mouth ulceration 59.64 41.56 21 2708 1734 1742318
Drug ineffective 59.13 41.56 78 2651 63723 1680329
Neutropenia 58.42 41.56 44 2685 18216 1725836
Hydronephrosis 57.05 41.56 19 2710 1326 1742726
Nephrogenic diabetes insipidus 55.73 41.56 13 2716 238 1743814
Leukopenia 55.53 41.56 32 2697 8448 1735604
Disease recurrence 55.21 41.56 22 2707 2560 1741492
Cachexia 53.87 41.56 17 2712 999 1743053
Transitional cell carcinoma 53.00 41.56 13 2716 297 1743755
Pneumocystis jirovecii pneumonia 52.77 41.56 21 2708 2435 1741617
Hepatitis B 52.34 41.56 18 2711 1385 1742667
Propionibacterium infection 51.99 41.56 9 2720 30 1744022
Hypertension 51.68 41.56 42 2687 19406 1724646
Acne 51.55 41.56 19 2710 1789 1742263
Scedosporium infection 51.49 41.56 11 2718 132 1743920
Chronic graft versus host disease 49.95 41.56 14 2715 544 1743508
Cow pox 49.76 41.56 7 2722 1 1744051
Pancytopenia 49.33 41.56 33 2696 11324 1732728
Protothecosis 48.93 41.56 7 2722 2 1744050
Haemolytic uraemic syndrome 48.28 41.56 13 2716 434 1743618
Diffuse large B-cell lymphoma 48.08 41.56 16 2713 1113 1742939
Abdominal pain 48.02 41.56 42 2687 21448 1722604
Herpes zoster meningoencephalitis 47.68 41.56 9 2720 54 1743998
Renal tubular atrophy 46.82 41.56 11 2718 208 1743844
Venoocclusive disease 46.12 41.56 12 2717 350 1743702
Escherichia infection 46.01 41.56 15 2714 978 1743074
Weight decreased 45.95 41.56 42 2687 22711 1721341
Basal cell carcinoma 45.70 41.56 19 2710 2464 1741588
Acute respiratory distress syndrome 45.32 41.56 21 2708 3530 1740522
Urinary tract infection 45.29 41.56 30 2699 10123 1733929
Aspergillus infection 45.02 41.56 16 2713 1357 1742695
Neuroendocrine carcinoma of the skin 44.61 41.56 10 2719 152 1743900
Acute graft versus host disease 44.18 41.56 14 2715 833 1743219
Graft versus host disease in skin 44.16 41.56 12 2717 415 1743637
Drug ineffective for unapproved indication 44.08 41.56 17 2712 1812 1742240
Drug interaction 44.02 41.56 45 2684 27913 1716139
Pharyngitis 43.88 41.56 15 2714 1133 1742919
Drug level increased 43.65 41.56 19 2710 2758 1741294
Meningitis viral 43.03 41.56 10 2719 180 1743872
Asthenia 42.68 41.56 49 2680 34621 1709431
Staphylococcal infection 42.56 41.56 22 2707 4685 1739367
Herpes simplex 42.46 41.56 13 2716 690 1743362
Heart transplant rejection 42.42 41.56 10 2719 192 1743860
Acute hepatic failure 42.26 41.56 17 2712 2026 1742026
Fluid overload 42.16 41.56 17 2712 2038 1742014

Pharmacologic Action:

SourceCodeDescription
ATC L04AA10 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
IMMUNOSUPPRESSANTS
IMMUNOSUPPRESSANTS
Selective immunosuppressants
ATC S01XA23 SENSORY ORGANS
OPHTHALMOLOGICALS
OTHER OPHTHALMOLOGICALS
Other ophthalmologicals
FDA PE N0000175550 Decreased Immunologic Activity
FDA EPC N0000175625 mTOR Inhibitor Immunosuppressant
FDA MoA N0000175624 mTOR Inhibitors
FDA EPC N0000175605 Kinase Inhibitor
FDA MoA N0000175076 Protein Kinase Inhibitors
MeSH PA D000900 Anti-Bacterial Agents
MeSH PA D000890 Anti-Infective Agents
MeSH PA D000903 Antibiotics, Antineoplastic
MeSH PA D000935 Antifungal Agents
MeSH PA D000970 Antineoplastic Agents
MeSH PA D007155 Immunologic Factors
MeSH PA D007166 Immunosuppressive Agents
CHEBI has role CHEBI:35705 immunosuppressive agent
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:36047 antibacterial drug

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Pulmonary lymphangioleiomyomatosis indication 277844007 DOID:3319
Renal cell carcinoma indication 702391001 DOID:4450
Prevention of Kidney Transplant Rejection indication
Coronavirus infection off-label use 186747009
Prevention of Cardiac Transplant Rejection off-label use
Hypercholesterolemia contraindication 13644009
Hyperbilirubinemia contraindication 14783006 DOID:2741
Transplantation of liver contraindication 18027006
Progressive multifocal leukoencephalopathy contraindication 22255007 DOID:643
Cytomegalovirus infection contraindication 28944009
Proteinuria contraindication 29738008 DOID:576
Hypertensive disorder contraindication 38341003 DOID:10763
Infectious disease contraindication 40733004
Body fluid retention contraindication 43498006
Gastrointestinal perforation contraindication 51875005
Hyperlipidemia contraindication 55822004 DOID:1168
Acute infectious disease contraindication 63171007
Interstitial pneumonia contraindication 64667001
Diabetes mellitus contraindication 73211009 DOID:9351
Hyperglycemia contraindication 80394007 DOID:4195
Transplant of lung contraindication 88039007
Kidney disease contraindication 90708001 DOID:557
Secondary malignant neoplasm of cerebrum contraindication 94248000
Malignant lymphoma contraindication 118600007 DOID:0060058
Perioperative care contraindication 133897009
Cerebrovascular accident contraindication 230690007
Interstitial lung disease contraindication 233703007 DOID:3082
Lymphedema contraindication 234097001 DOID:4977
Disease of liver contraindication 235856003 DOID:409
Impaired wound healing contraindication 271618001
Peripheral edema contraindication 271809000
Pregnancy, function contraindication 289908002
Hypertriglyceridemia contraindication 302870006
Primary malignant neoplasm contraindication 372087000
Malignant neoplasm of skin contraindication 372130007 DOID:4159
Pericardial effusion contraindication 373945007 DOID:118
Surgical procedure contraindication 387713003
Ascites contraindication 389026000
Breastfeeding (mother) contraindication 413712001
Pneumocystosis jiroveci pneumonia contraindication 415125002 DOID:11339
Malignant neoplasm of brain contraindication 428061005 DOID:1319
Bronchial Anastomotic Dehiscence in Lung Transplant contraindication
BK Polyomavirus Reactivation Nephropathy contraindication
Sirolimus Toxicity contraindication
Hepatic Artery Thrombosis in Liver Transplant contraindication
Pleural Effusions contraindication

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 10.5 acidic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
1MG/ML RAPAMUNE PF PRISM CV N021083 Sept. 15, 1999 RX SOLUTION ORAL May 28, 2022 TREATMENT OF LYMPHANGIOLEIOMYOMATOSIS (LAM)
0.5MG RAPAMUNE PF PRISM CV N021110 Jan. 25, 2010 RX TABLET ORAL May 28, 2022 TREATMENT OF LYMPHANGIOLEIOMYOMATOSIS (LAM)
1MG RAPAMUNE PF PRISM CV N021110 Aug. 25, 2000 RX TABLET ORAL May 28, 2022 TREATMENT OF LYMPHANGIOLEIOMYOMATOSIS (LAM)
2MG RAPAMUNE PF PRISM CV N021110 Aug. 22, 2002 RX TABLET ORAL May 28, 2022 TREATMENT OF LYMPHANGIOLEIOMYOMATOSIS (LAM)
5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** RAPAMUNE PF PRISM CV N021110 Feb. 23, 2004 DISCN TABLET ORAL May 28, 2022 TREATMENT OF LYMPHANGIOLEIOMYOMATOSIS (LAM)

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Peptidyl-prolyl cis-trans isomerase FKBP1A Enzyme INHIBITOR Kd 8.96 WOMBAT-PK CHEMBL
Cytochrome P450 3A4 Enzyme IC50 5.70 DRUG MATRIX
Cytochrome P450 2C9 Enzyme IC50 5.70 DRUG MATRIX
Cytochrome P450 2C19 Enzyme IC50 5.40 DRUG MATRIX
Sodium/nucleoside cotransporter 1 Transporter Ki 6.43 DRUG MATRIX
Peptidyl-prolyl cis-trans isomerase FKBP3 Enzyme Kd 9.70 WOMBAT-PK
Multidrug resistance protein 1 Transporter IC50 6.20 WOMBAT-PK
Serine/threonine-protein kinase mTOR Kinase IC50 10 CHEMBL
Eukaryotic translation initiation factor 4E Nuclear other Kd 9.30 CHEMBL
Programmed cell death protein 4 Unclassified EC50 7.30 CHEMBL
Peptidyl-prolyl cis-trans isomerase FKBP5 Enzyme Ki 8.52 CHEMBL
Peptidyl-prolyl cis-trans isomerase FKBP1B Enzyme Kd 9.70 CHEMBL

External reference:

IDSource
4021176 VUID
N0000148624 NUI
C0072980 UMLSCUI
D00753 KEGG_DRUG
116109004 SNOMEDCT_US
4021176 VANDF
387014003 SNOMEDCT_US
007885 NDDF
35302 RXNORM
8303 MMSL
d04453 MMSL
210889 MMSL
CHEMBL413 ChEMBL_ID
DB00877 DRUGBANK_ID
W36ZG6FT64 UNII
7104 INN_ID
CHEBI:9168 CHEBI
D020123 MESH_DESCRIPTOR_UI
5284616 PUBCHEM_CID
6031 IUPHAR_LIGAND_ID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Rapamune HUMAN PRESCRIPTION DRUG LABEL 1 0008-1030 SOLUTION 1 mg ORAL NDA 22 sections
Rapamune HUMAN PRESCRIPTION DRUG LABEL 1 0008-1040 TABLET, SUGAR COATED 0.50 mg ORAL NDA 22 sections
Rapamune HUMAN PRESCRIPTION DRUG LABEL 1 0008-1041 TABLET, SUGAR COATED 1 mg ORAL NDA 22 sections
Rapamune HUMAN PRESCRIPTION DRUG LABEL 1 0008-1042 TABLET, SUGAR COATED 2 mg ORAL NDA 22 sections
Sirolimus HUMAN PRESCRIPTION DRUG LABEL 1 50268-718 TABLET 1 mg ORAL ANDA 20 sections
Sirolimus HUMAN PRESCRIPTION DRUG LABEL 1 55111-653 TABLET 1 mg ORAL ANDA 20 sections
Sirolimus HUMAN PRESCRIPTION DRUG LABEL 1 55111-654 TABLET 2 mg ORAL ANDA 20 sections
Sirolimus HUMAN PRESCRIPTION DRUG LABEL 1 59762-1001 TABLET, SUGAR COATED 0.50 mg ORAL NDA AUTHORIZED GENERIC 21 sections
Sirolimus HUMAN PRESCRIPTION DRUG LABEL 1 59762-1002 TABLET, SUGAR COATED 1 mg ORAL NDA AUTHORIZED GENERIC 21 sections
Sirolimus HUMAN PRESCRIPTION DRUG LABEL 1 59762-1003 TABLET, SUGAR COATED 2 mg ORAL NDA AUTHORIZED GENERIC 21 sections
Sirolimus HUMAN PRESCRIPTION DRUG LABEL 1 59762-1205 SOLUTION 1 mg ORAL NDA AUTHORIZED GENERIC 22 sections
Sirolimus HUMAN PRESCRIPTION DRUG LABEL 1 60505-6197 SOLUTION 1 mg ORAL ANDA 21 sections
sirolimus HUMAN PRESCRIPTION DRUG LABEL 1 65841-771 TABLET, FILM COATED 0.50 mg ORAL ANDA 21 sections
Sirolimus HUMAN PRESCRIPTION DRUG LABEL 1 66689-347 SOLUTION 1 mg ORAL ANDA 21 sections
Sirolimus HUMAN PRESCRIPTION DRUG LABEL 1 68084-915 TABLET 1 mg ORAL ANDA 21 sections
sirolimus HUMAN PRESCRIPTION DRUG LABEL 1 68382-520 TABLET, FILM COATED 0.50 mg ORAL ANDA 21 sections
Sirolimus HUMAN PRESCRIPTION DRUG LABEL 1 69238-1594 SOLUTION 1 mg ORAL ANDA 20 sections