mercaptamine 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | 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
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 | 131.91 | 55.39 | 29 | 313 | 21942 | 63466738 |
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 | 105.41 | 43.25 | 23 | 390 | 7538 | 34948980 |
| Amino acid level increased | 73.33 | 43.25 | 11 | 402 | 431 | 34956087 |
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 | 95.69 | 37.91 | 14 | 600 | 714 | 79743060 |
| Vomiting | 61.46 | 37.91 | 46 | 568 | 665782 | 79077992 |
| Renal transplant | 58.74 | 37.91 | 11 | 603 | 2536 | 79741238 |
| Eye irritation | 48.99 | 37.91 | 14 | 600 | 20667 | 79723107 |
| Treatment noncompliance | 39.85 | 37.91 | 15 | 599 | 52253 | 79691521 |
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:66987 | radiation protective drugs |
| CHEBI has role | CHEBI:75771 | Mus musculus metabolites |
| CHEBI has role | CHEBI:77746 | Homo sapiens metabolite |
| CHEBI has role | CHEBI:176497 | geroprotectors |
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)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| EQ 25MG BASE | PROCYSBI | HORIZON | N203389 | April 30, 2013 | RX | CAPSULE, DELAYED RELEASE | ORAL | Feb. 14, 2023 | PEDIATRIC EXCLUSIVITY |
| EQ 75MG BASE | PROCYSBI | HORIZON | N203389 | April 30, 2013 | RX | CAPSULE, DELAYED RELEASE | ORAL | Feb. 14, 2023 | PEDIATRIC EXCLUSIVITY |
| EQ 300MG BASE/PACKET | PROCYSBI | HORIZON | N213491 | Feb. 14, 2020 | RX | GRANULE, DELAYED RELEASE | ORAL | Feb. 14, 2023 | PEDIATRIC EXCLUSIVITY |
| EQ 75MG BASE/PACKET | PROCYSBI | HORIZON | N213491 | Feb. 14, 2020 | RX | GRANULE, DELAYED RELEASE | ORAL | Feb. 14, 2023 | PEDIATRIC EXCLUSIVITY |
| EQ 0.37% BASE | CYSTADROPS | RECORDATI RARE | N211302 | Aug. 19, 2020 | RX | SOLUTION/DROPS | OPHTHALMIC | Aug. 19, 2023 | NEW PRODUCT |
| EQ 25MG BASE | PROCYSBI | HORIZON | N203389 | April 30, 2013 | RX | CAPSULE, DELAYED RELEASE | ORAL | Dec. 22, 2024 | TREATMENT OF NEPHROPATHIC CYSTINOSIS IN PEDIATRIC PATIENTS 1 YEAR OF AGE TO LESS THAN 2 YEARS OF AGE |
| EQ 75MG BASE | PROCYSBI | HORIZON | N203389 | April 30, 2013 | RX | CAPSULE, DELAYED RELEASE | ORAL | Dec. 22, 2024 | TREATMENT OF NEPHROPATHIC CYSTINOSIS IN PEDIATRIC PATIENTS 1 YEAR OF AGE TO LESS THAN 2 YEARS OF AGE |
| EQ 300MG BASE/PACKET | PROCYSBI | HORIZON | N213491 | Feb. 14, 2020 | RX | GRANULE, DELAYED RELEASE | ORAL | Dec. 22, 2024 | FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S) |
| EQ 75MG BASE/PACKET | PROCYSBI | HORIZON | N213491 | Feb. 14, 2020 | RX | GRANULE, DELAYED RELEASE | ORAL | Dec. 22, 2024 | FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S) |
| EQ 25MG BASE | PROCYSBI | HORIZON | N203389 | April 30, 2013 | RX | CAPSULE, DELAYED RELEASE | ORAL | June 22, 2025 | PEDIATRIC EXCLUSIVITY |
| EQ 75MG BASE | PROCYSBI | HORIZON | N203389 | April 30, 2013 | RX | CAPSULE, DELAYED RELEASE | ORAL | June 22, 2025 | PEDIATRIC EXCLUSIVITY |
| EQ 300MG BASE/PACKET | PROCYSBI | HORIZON | N213491 | Feb. 14, 2020 | RX | GRANULE, DELAYED RELEASE | ORAL | June 22, 2025 | PEDIATRIC EXCLUSIVITY |
| EQ 75MG BASE/PACKET | PROCYSBI | HORIZON | N213491 | Feb. 14, 2020 | RX | GRANULE, DELAYED RELEASE | ORAL | June 22, 2025 | PEDIATRIC EXCLUSIVITY |
Bioactivity Summary:
None
External reference:
| ID | Source |
|---|---|
| 4020891 | VUID |
| N0000179403 | NUI |
| D03634 | KEGG_DRUG |
| 27761-19-9 | SECONDARY_CAS_RN |
| 156-57-0 | SECONDARY_CAS_RN |
| 1421468 | RXNORM |
| 4020891 | VANDF |
| 4023983 | VANDF |
| 4032349 | VANDF |
| C0010648 | UMLSCUI |
| CHEBI:17141 | CHEBI |
| CHEMBL602 | ChEMBL_ID |
| 6058 | PUBCHEM_CID |
| DB00847 | DRUGBANK_ID |
| CHEMBL1256137 | ChEMBL_ID |
| CHEMBL2062263 | ChEMBL_ID |
| 7440 | IUPHAR_LIGAND_ID |
| 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 |
| 5UX2SD1KE2 | UNII |
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 | 0378-9040 | CAPSULE | 50 mg | ORAL | NDA | 25 sections |
| Cystagon | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0378-9045 | CAPSULE | 150 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 | 54482-020 | SOLUTION | 6.50 mg | OPHTHALMIC | NDA | 25 sections |
| CYSTARAN | HUMAN PRESCRIPTION DRUG LABEL | 1 | 54482-020 | SOLUTION | 6.50 mg | OPHTHALMIC | NDA | 25 sections |
| CYSTADROPS | HUMAN PRESCRIPTION DRUG LABEL | 1 | 55292-410 | SOLUTION | 3.50 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 | 75987-100 | 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 | 75987-101 | 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 | 75987-140 | 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 |
| PROCYSBI | HUMAN PRESCRIPTION DRUG LABEL | 1 | 75987-145 | GRANULE, DELAYED RELEASE | 300 mg | ORAL | NDA | 29 sections |