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mercaptamine 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| aptamers, classical and mirror ones | 768 | 60-23-1 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
A mercaptoethylamine compound that is endogenously derived from the COENZYME A degradative pathway. The fact that cysteamine is readily transported into LYSOSOMES where it reacts with CYSTINE to form cysteine-cysteamine disulfide and CYSTEINE has led to its use in CYSTINE DEPLETING AGENTS for the treatment of CYSTINOSIS.
|
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 2 | g | O |
ADMET properties:
None
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| kinase-safety-class | ACVR2A,ACVR2B,AKT2,AKT3,ALK,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK1,CDK4,CDK5,CDK9,CHEK1,DDR1,DYRK1B,EIF2AK3,EPHB4,ERBB2,FLT3,GRK2,IKBKB,IRAK1,IRAK4,ITK,JAK1,JAK2,JAK3,KDR,MAP2K6,MAP3K14,MAP3K21,MAP3K7,MAP4K1,MAP4K3,MAPK10,MAPK7,MAPK9,MAPKAPK2,MARK4,MET,MTOR,NTRK2,PDK2,PDK4,PDPK1,PIK3CB,PIM2,PRKCD,PRKDC,SIK2,SIK3,STK33,SYK,TEK,TGFBR1,TTK,ULK1,ZAP70 | 60 | |||
| kinase-selectivity-class | AKT3,BRAF,CAMK2A,CAMK2B,CAMK2D,CDK4,CHEK1,CLK2,DYRK1B,EIF2AK3,GAK,IRAK4,MAP3K7,MAP4K1,MAP4K3,MARK4,MELK,PAK4,PDPK1,PRKCD,SIK2,SIK3,STK33,SYK,TTK,ULK2 | 26 | |||
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| June 23, 1997 | EMA | ||
| Aug. 15, 1994 | FDA | MYLAN |
FDA Adverse Event Reporting System (Female)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Eye irritation | 131.52 | 53.89 | 31 | 424 | 33947 | 90594045 |
FDA Adverse Event Reporting System (Male)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Eye irritation | 111.19 | 46.33 | 26 | 490 | 11292 | 42609527 |
| Amino acid level increased | 71.40 | 46.33 | 11 | 505 | 502 | 42620317 |
| Transplant rejection | 48.57 | 46.33 | 14 | 502 | 13574 | 42607245 |
FDA Adverse Event Reporting System (Geriatric)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Amino acid level increased | 103.23 | 39.89 | 15 | 742 | 821 | 110587721 |
| Fibrosing colonopathy | 73.78 | 39.89 | 7 | 750 | 3 | 110588539 |
| Renal transplant | 57.38 | 39.89 | 11 | 746 | 3227 | 110585315 |
| Vomiting | 55.31 | 39.89 | 47 | 710 | 910628 | 109677914 |
| Transplant rejection | 48.20 | 39.89 | 14 | 743 | 24553 | 110563989 |
| Eye irritation | 43.94 | 39.89 | 14 | 743 | 33438 | 110555104 |
| Treatment noncompliance | 43.64 | 39.89 | 17 | 740 | 72973 | 110515569 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | A16AA04 | ALIMENTARY TRACT AND METABOLISM OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS Amino acids and derivatives |
| ATC | S01XA21 | SENSORY ORGANS OPHTHALMOLOGICALS OTHER OPHTHALMOLOGICALS Other ophthalmologicals |
| FDA MoA | N0000175549 | Cystine Disulfide Reduction |
| MeSH PA | D065104 | Cystine Depleting Agents |
| FDA EPC | N0000187051 | Cystine Depleting Agent |
| CHEBI has role | CHEBI:22587 | antiviral agent |
| CHEBI has role | CHEBI:33281 | antimicrobial agent |
| CHEBI has role | CHEBI:64946 | anti-HIV agent |
| CHEBI has role | CHEBI:66981 | ophthalmology drug |
| CHEBI has role | CHEBI:66987 | radiation protective agent |
| CHEBI has role | CHEBI:75771 | mouse metabolite |
| CHEBI has role | CHEBI:77746 | human metabolite |
| CHEBI has role | CHEBI:176497 | geroprotector |
Related Drugs by ATC class:
A16AA Amino acids and derivatives 6 drugs
S01XA Other ophthalmologicals 24 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Cystinosis | indication | 190681003 | |
| Depressive disorder | contraindication | 35489007 | |
| Gastrointestinal ulcer | contraindication | 40845000 | |
| Benign intracranial hypertension | contraindication | 68267002 | DOID:11459 |
| Gastrointestinal hemorrhage | contraindication | 74474003 | |
| Disorder of brain | contraindication | 81308009 | DOID:936 |
| Leukopenia | contraindication | 84828003 | DOID:615 |
| Disorder of skin | contraindication | 95320005 | DOID:37 |
| Fracture of bone | contraindication | 125605004 | |
| Seizure disorder | contraindication | 128613002 | |
| Disease of liver | contraindication | 235856003 | DOID:409 |
| Osteopenia | contraindication | 312894000 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 10.54 | acidic |
| pKa2 | 9.41 | Basic |
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| EQ 25MG BASE | PROCYSBI | HORIZON | N203389 | April 30, 2013 | RX | CAPSULE, DELAYED RELEASE | ORAL | 9192590 | Jan. 26, 2027 | MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES |
| EQ 25MG BASE | PROCYSBI | HORIZON | N203389 | April 30, 2013 | RX | CAPSULE, DELAYED RELEASE | ORAL | 9198882 | Jan. 26, 2027 | MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES |
| EQ 25MG BASE | PROCYSBI | HORIZON | N203389 | April 30, 2013 | RX | CAPSULE, DELAYED RELEASE | ORAL | 9925156 | Jan. 26, 2027 | MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES |
| EQ 25MG BASE | PROCYSBI | HORIZON | N203389 | April 30, 2013 | RX | CAPSULE, DELAYED RELEASE | ORAL | 9925157 | Jan. 26, 2027 | MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES |
| EQ 25MG BASE | PROCYSBI | HORIZON | N203389 | April 30, 2013 | RX | CAPSULE, DELAYED RELEASE | ORAL | 9925158 | Jan. 26, 2027 | MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES |
| EQ 75MG BASE | PROCYSBI | HORIZON | N203389 | April 30, 2013 | RX | CAPSULE, DELAYED RELEASE | ORAL | 9192590 | Jan. 26, 2027 | MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES |
| EQ 75MG BASE | PROCYSBI | HORIZON | N203389 | April 30, 2013 | RX | CAPSULE, DELAYED RELEASE | ORAL | 9198882 | Jan. 26, 2027 | MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES |
| EQ 75MG BASE | PROCYSBI | HORIZON | N203389 | April 30, 2013 | RX | CAPSULE, DELAYED RELEASE | ORAL | 9925156 | Jan. 26, 2027 | MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES |
| EQ 75MG BASE | PROCYSBI | HORIZON | N203389 | April 30, 2013 | RX | CAPSULE, DELAYED RELEASE | ORAL | 9925157 | Jan. 26, 2027 | MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES |
| EQ 75MG BASE | PROCYSBI | HORIZON | N203389 | April 30, 2013 | RX | CAPSULE, DELAYED RELEASE | ORAL | 9925158 | Jan. 26, 2027 | MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES |
| EQ 300MG BASE/PACKET | PROCYSBI | HORIZON | N213491 | Feb. 14, 2020 | RX | GRANULE, DELAYED RELEASE | ORAL | 9192590 | Jan. 26, 2027 | MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES |
| EQ 300MG BASE/PACKET | PROCYSBI | HORIZON | N213491 | Feb. 14, 2020 | RX | GRANULE, DELAYED RELEASE | ORAL | 9198882 | Jan. 26, 2027 | MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES |
| EQ 300MG BASE/PACKET | PROCYSBI | HORIZON | N213491 | Feb. 14, 2020 | RX | GRANULE, DELAYED RELEASE | ORAL | 9925156 | Jan. 26, 2027 | MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES |
| EQ 300MG BASE/PACKET | PROCYSBI | HORIZON | N213491 | Feb. 14, 2020 | RX | GRANULE, DELAYED RELEASE | ORAL | 9925157 | Jan. 26, 2027 | MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES |
| EQ 300MG BASE/PACKET | PROCYSBI | HORIZON | N213491 | Feb. 14, 2020 | RX | GRANULE, DELAYED RELEASE | ORAL | 9925158 | Jan. 26, 2027 | MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES |
| EQ 75MG BASE/PACKET | PROCYSBI | HORIZON | N213491 | Feb. 14, 2020 | RX | GRANULE, DELAYED RELEASE | ORAL | 9192590 | Jan. 26, 2027 | MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES |
| EQ 75MG BASE/PACKET | PROCYSBI | HORIZON | N213491 | Feb. 14, 2020 | RX | GRANULE, DELAYED RELEASE | ORAL | 9198882 | Jan. 26, 2027 | MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES |
| EQ 75MG BASE/PACKET | PROCYSBI | HORIZON | N213491 | Feb. 14, 2020 | RX | GRANULE, DELAYED RELEASE | ORAL | 9925156 | Jan. 26, 2027 | MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES |
| EQ 75MG BASE/PACKET | PROCYSBI | HORIZON | N213491 | Feb. 14, 2020 | RX | GRANULE, DELAYED RELEASE | ORAL | 9925157 | Jan. 26, 2027 | MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES |
| EQ 75MG BASE/PACKET | PROCYSBI | HORIZON | N213491 | Feb. 14, 2020 | RX | GRANULE, DELAYED RELEASE | ORAL | 9925158 | Jan. 26, 2027 | MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES |
| EQ 25MG BASE | PROCYSBI | HORIZON | N203389 | April 30, 2013 | RX | CAPSULE, DELAYED RELEASE | ORAL | 8026284 | Sept. 22, 2027 | MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES |
| EQ 75MG BASE | PROCYSBI | HORIZON | N203389 | April 30, 2013 | RX | CAPSULE, DELAYED RELEASE | ORAL | 8026284 | Sept. 22, 2027 | MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES |
| EQ 300MG BASE/PACKET | PROCYSBI | HORIZON | N213491 | Feb. 14, 2020 | RX | GRANULE, DELAYED RELEASE | ORAL | 8026284 | Sept. 22, 2027 | MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES |
| EQ 75MG BASE/PACKET | PROCYSBI | HORIZON | N213491 | Feb. 14, 2020 | RX | GRANULE, DELAYED RELEASE | ORAL | 8026284 | Sept. 22, 2027 | MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES |
| EQ 25MG BASE | PROCYSBI | HORIZON | N203389 | April 30, 2013 | RX | CAPSULE, DELAYED RELEASE | ORAL | 10143665 | Aug. 16, 2036 | MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES |
| EQ 25MG BASE | PROCYSBI | HORIZON | N203389 | April 30, 2013 | RX | CAPSULE, DELAYED RELEASE | ORAL | 10328037 | Aug. 16, 2036 | MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES |
| EQ 25MG BASE | PROCYSBI | HORIZON | N203389 | April 30, 2013 | RX | CAPSULE, DELAYED RELEASE | ORAL | 10548859 | Aug. 16, 2036 | MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES |
| EQ 25MG BASE | PROCYSBI | HORIZON | N203389 | April 30, 2013 | RX | CAPSULE, DELAYED RELEASE | ORAL | 10905662 | Aug. 16, 2036 | MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES |
| EQ 75MG BASE | PROCYSBI | HORIZON | N203389 | April 30, 2013 | RX | CAPSULE, DELAYED RELEASE | ORAL | 10143665 | Aug. 16, 2036 | MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES |
| EQ 75MG BASE | PROCYSBI | HORIZON | N203389 | April 30, 2013 | RX | CAPSULE, DELAYED RELEASE | ORAL | 10328037 | Aug. 16, 2036 | MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES |
| EQ 75MG BASE | PROCYSBI | HORIZON | N203389 | April 30, 2013 | RX | CAPSULE, DELAYED RELEASE | ORAL | 10548859 | Aug. 16, 2036 | MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES |
| EQ 75MG BASE | PROCYSBI | HORIZON | N203389 | April 30, 2013 | RX | CAPSULE, DELAYED RELEASE | ORAL | 10905662 | Aug. 16, 2036 | MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES |
| EQ 300MG BASE/PACKET | PROCYSBI | HORIZON | N213491 | Feb. 14, 2020 | RX | GRANULE, DELAYED RELEASE | ORAL | 10143665 | Aug. 16, 2036 | MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES |
| EQ 300MG BASE/PACKET | PROCYSBI | HORIZON | N213491 | Feb. 14, 2020 | RX | GRANULE, DELAYED RELEASE | ORAL | 10328037 | Aug. 16, 2036 | MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES |
| EQ 300MG BASE/PACKET | PROCYSBI | HORIZON | N213491 | Feb. 14, 2020 | RX | GRANULE, DELAYED RELEASE | ORAL | 10548859 | Aug. 16, 2036 | MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES |
| EQ 300MG BASE/PACKET | PROCYSBI | HORIZON | N213491 | Feb. 14, 2020 | RX | GRANULE, DELAYED RELEASE | ORAL | 10905662 | Aug. 16, 2036 | MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES |
| EQ 75MG BASE/PACKET | PROCYSBI | HORIZON | N213491 | Feb. 14, 2020 | RX | GRANULE, DELAYED RELEASE | ORAL | 10143665 | Aug. 16, 2036 | MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES |
| EQ 75MG BASE/PACKET | PROCYSBI | HORIZON | N213491 | Feb. 14, 2020 | RX | GRANULE, DELAYED RELEASE | ORAL | 10328037 | Aug. 16, 2036 | MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES |
| EQ 75MG BASE/PACKET | PROCYSBI | HORIZON | N213491 | Feb. 14, 2020 | RX | GRANULE, DELAYED RELEASE | ORAL | 10548859 | Aug. 16, 2036 | MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES |
| EQ 75MG BASE/PACKET | PROCYSBI | HORIZON | N213491 | Feb. 14, 2020 | RX | GRANULE, DELAYED RELEASE | ORAL | 10905662 | Aug. 16, 2036 | MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES |
Orange Book exclusivity data (new drug applications)
None
Bioactivity Summary:
None
External reference:
| ID | Source |
|---|---|
| 4020891 | VUID |
| N0000179403 | NUI |
| D03634 | KEGG_DRUG |
| 27761-19-9 | SECONDARY_CAS_RN |
| 1421468 | RXNORM |
| C0010648 | UMLSCUI |
| CHEBI:17141 | CHEBI |
| CHEMBL602 | ChEMBL_ID |
| 6058 | PUBCHEM_CID |
| DB00847 | DRUGBANK_ID |
| CHEMBL1256137 | ChEMBL_ID |
| CHEMBL1200577 | ChEMBL_ID |
| 7440 | IUPHAR_LIGAND_ID |
| 156-57-0 | SECONDARY_CAS_RN |
| 201127 | MMSL |
| 33306 | MMSL |
| 36492 | MMSL |
| 4523 | MMSL |
| 4954 | MMSL |
| d03794 | MMSL |
| 003510 | NDDF |
| 004750 | NDDF |
| 013719 | NDDF |
| 109109007 | SNOMEDCT_US |
| 109111003 | SNOMEDCT_US |
| 373457005 | SNOMEDCT_US |
| 442508008 | SNOMEDCT_US |
| D003543 | MESH_DESCRIPTOR_UI |
| DHL | PDB_CHEM_ID |
| SEA | PDB_CHEM_ID |
| 195 | INN_ID |
| 4020891 | VANDF |
| 4023983 | VANDF |
| 4032349 | VANDF |
| 5UX2SD1KE2 | UNII |
| 5UX2SD1KE2 | INXIGHT DRUGS |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Cystagon | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0378-9040 | CAPSULE | 50 mg | ORAL | NDA | 25 sections |
| Cystagon | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0378-9045 | CAPSULE | 150 mg | ORAL | NDA | 25 sections |
| CYSTARAN | HUMAN PRESCRIPTION DRUG LABEL | 1 | 54482-020 | SOLUTION | 6.50 mg | OPHTHALMIC | NDA | 25 sections |
| CYSTARAN | HUMAN PRESCRIPTION DRUG LABEL | 1 | 54482-035 | SOLUTION | 6.50 mg | OPHTHALMIC | NDA | 25 sections |
| CYSTADROPS | HUMAN PRESCRIPTION DRUG LABEL | 1 | 55292-410 | SOLUTION | 3.50 mg | OPHTHALMIC | NDA | 25 sections |
| PROCYSBI | HUMAN PRESCRIPTION DRUG LABEL | 1 | 75987-100 | CAPSULE, DELAYED RELEASE PELLETS | 25 mg | ORAL | NDA | 29 sections |
| PROCYSBI | HUMAN PRESCRIPTION DRUG LABEL | 1 | 75987-101 | CAPSULE, DELAYED RELEASE PELLETS | 75 mg | ORAL | NDA | 29 sections |
| PROCYSBI | HUMAN PRESCRIPTION DRUG LABEL | 1 | 75987-140 | GRANULE, DELAYED RELEASE | 75 mg | ORAL | NDA | 29 sections |
| PROCYSBI | HUMAN PRESCRIPTION DRUG LABEL | 1 | 75987-145 | GRANULE, DELAYED RELEASE | 300 mg | ORAL | NDA | 29 sections |