mercaptamine 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
aptamers, classical and mirror ones 768 60-23-1

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • mercaptamine hydrochloride
  • mercaptamine bitartrate
  • mercaptamine
  • cysteamine
  • thioethanolamine
  • 2-mercaptoethylamine
  • mercamine
  • mercaptamin
  • mercaptoethylamine
  • cysteamine bitartrate
  • procysbi
  • cystagon
  • cysteamine hydrochloride
  • cysteamine HCl
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.
  • Molecular weight: 77.15
  • Formula: C2H7NS
  • CLOGP: -0.25
  • LIPINSKI: 0
  • HAC: 1
  • HDO: 1
  • TPSA: 26.02
  • ALOGS: -0.52
  • ROTB: 1

Drug dosage:

DoseUnitRoute
2 g O

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
June 23, 1997 EMA
Aug. 15, 1994 FDA MYLAN

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
Eye irritation 131.91 55.39 29 313 21942 63466738

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
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 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
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:

SourceCodeDescription
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|

DiseaseRelationSNOMED_IDDOID
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 levelDissociation constantType (acidic/basic)
pKa1 10.54 acidic
pKa2 9.41 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent 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 strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
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:

IDSource
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:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
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