Stem definition | Drug id | CAS RN |
---|---|---|
antibiotics, protein-synthesis inhibitors, tetracycline derivatives | 5298 | 1035654-66-0 |
Dose | Unit | Route |
---|---|---|
0.10 | g | O |
None
Date | Agency | Company | Orphan |
---|---|---|---|
Oct. 1, 2018 | FDA | ALLERGAN INC |
None
None
None
None
Source | Code | Description |
---|---|---|
ATC | J01AA14 | ANTIINFECTIVES FOR SYSTEMIC USE ANTIBACTERIALS FOR SYSTEMIC USE TETRACYCLINES Tetracyclines |
MeSH PA | D000900 | Anti-Bacterial Agents |
MeSH PA | D000890 | Anti-Infective Agents |
MeSH PA | D003879 | Dermatologic Agents |
FDA CS | M0021223 | Tetracyclines |
FDA EPC | N0000175882 | Tetracycline-class Drug |
FDA MoA | N0000185503 | P-Glycoprotein Inhibitors |
Disease | Relation | SNOMED_ID | DOID |
---|---|---|---|
Acne vulgaris | indication | 88616000 |
None
None
Dissociation level | Dissociation constant | Type (acidic/basic) |
---|---|---|
pKa1 | 3.13 | acidic |
pKa2 | 8.56 | acidic |
pKa3 | 10.08 | acidic |
pKa4 | 11.96 | acidic |
pKa5 | 13.08 | acidic |
pKa6 | 9.41 | Basic |
pKa7 | 2.23 | Basic |
Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
---|---|---|---|---|---|---|---|---|---|---|
EQ 100MG BASE | SEYSARA | ALMIRALL | N209521 | Oct. 1, 2018 | RX | TABLET | ORAL | 9481639 | Aug. 10, 2028 | A METHOD FOR TREATING ACNE IN INFLAMMATORY LESIONS OF NON-NODULAR MODERATE TO SEVERE ACNE VULGARIS PATIENTS 9 YEARS OF AGE AND OLDER COMPRISING ADMINISTERING SARECYCLINE HYDROCHLORIDE IN 60 MG, 100 MG OR 150 MG EQUIVALENT DOSES |
EQ 150MG BASE | SEYSARA | ALMIRALL | N209521 | Oct. 1, 2018 | RX | TABLET | ORAL | 9481639 | Aug. 10, 2028 | A METHOD FOR TREATING ACNE IN INFLAMMATORY LESIONS OF NON-NODULAR MODERATE TO SEVERE ACNE VULGARIS PATIENTS 9 YEARS OF AGE AND OLDER COMPRISING ADMINISTERING SARECYCLINE HYDROCHLORIDE IN 60 MG, 100 MG OR 150 MG EQUIVALENT DOSES |
EQ 60MG BASE | SEYSARA | ALMIRALL | N209521 | Oct. 1, 2018 | RX | TABLET | ORAL | 9481639 | Aug. 10, 2028 | A METHOD FOR TREATING ACNE IN INFLAMMATORY LESIONS OF NON-NODULAR MODERATE TO SEVERE ACNE VULGARIS PATIENTS 9 YEARS OF AGE AND OLDER COMPRISING ADMINISTERING SARECYCLINE HYDROCHLORIDE IN 60 MG, 100 MG OR 150 MG EQUIVALENT DOSES |
EQ 100MG BASE | SEYSARA | ALMIRALL | N209521 | Oct. 1, 2018 | RX | TABLET | ORAL | 8513223 | Dec. 7, 2029 | A METHOD FOR TREATING A PATIENT 9 YEARS OF AGE AND OLDER SUFFERING FROM AN INFLAMMATORY SKIN DISORDER OF NON-NODULAR MODERATE TO SEVERE ACNE VULGARIS COMPRISING ADMINISTERING AN EFFECTIVE AMOUNT OF SARECYCLINE HYDROCHLORIDE |
EQ 150MG BASE | SEYSARA | ALMIRALL | N209521 | Oct. 1, 2018 | RX | TABLET | ORAL | 8513223 | Dec. 7, 2029 | A METHOD FOR TREATING A PATIENT 9 YEARS OF AGE AND OLDER SUFFERING FROM AN INFLAMMATORY SKIN DISORDER OF NON-NODULAR MODERATE TO SEVERE ACNE VULGARIS COMPRISING ADMINISTERING AN EFFECTIVE AMOUNT OF SARECYCLINE HYDROCHLORIDE |
EQ 60MG BASE | SEYSARA | ALMIRALL | N209521 | Oct. 1, 2018 | RX | TABLET | ORAL | 8513223 | Dec. 7, 2029 | A METHOD FOR TREATING A PATIENT 9 YEARS OF AGE AND OLDER SUFFERING FROM AN INFLAMMATORY SKIN DISORDER OF NON-NODULAR MODERATE TO SEVERE ACNE VULGARIS COMPRISING ADMINISTERING AN EFFECTIVE AMOUNT OF SARECYCLINE HYDROCHLORIDE |
EQ 100MG BASE | SEYSARA | ALMIRALL | N209521 | Oct. 1, 2018 | RX | TABLET | ORAL | 8318706 | May 1, 2031 | A METHOD FOR TREATING A BACTERIAL INFECTION IN INFLAMMATORY LESIONS OF NON-NODULAR MODERATE TO SEVERE ACNE VULGARIS PATIENTS 9 YEARS OF AGE AND OLDER COMPRISING ADMINISTERING AN EFFECTIVE AMOUNT OF SARECYCLINE HYDROCHLORIDE |
EQ 150MG BASE | SEYSARA | ALMIRALL | N209521 | Oct. 1, 2018 | RX | TABLET | ORAL | 8318706 | May 1, 2031 | A METHOD FOR TREATING A BACTERIAL INFECTION IN INFLAMMATORY LESIONS OF NON-NODULAR MODERATE TO SEVERE ACNE VULGARIS PATIENTS 9 YEARS OF AGE AND OLDER COMPRISING ADMINISTERING AN EFFECTIVE AMOUNT OF SARECYCLINE HYDROCHLORIDE |
EQ 60MG BASE | SEYSARA | ALMIRALL | N209521 | Oct. 1, 2018 | RX | TABLET | ORAL | 8318706 | May 1, 2031 | A METHOD FOR TREATING A BACTERIAL INFECTION IN INFLAMMATORY LESIONS OF NON-NODULAR MODERATE TO SEVERE ACNE VULGARIS PATIENTS 9 YEARS OF AGE AND OLDER COMPRISING ADMINISTERING AN EFFECTIVE AMOUNT OF SARECYCLINE HYDROCHLORIDE |
EQ 100MG BASE | SEYSARA | ALMIRALL | N209521 | Oct. 1, 2018 | RX | TABLET | ORAL | 9255068 | Feb. 9, 2033 | A METHOD FOR TREATING A BACTERIAL INFECTION IN INFLAMMATORY LESIONS OF NON-NODULAR MODERATE TO SEVERE ACNE VULGARIS PATIENTS 9 YEARS OF AGE AND OLDER COMPRISING ADMINISTERING AN EFFECTIVE AMOUNT OF SARECYCLINE HYDROCHLORIDE CRYSTALLINE SALT |
EQ 100MG BASE | SEYSARA | ALMIRALL | N209521 | Oct. 1, 2018 | RX | TABLET | ORAL | 9255068 | Feb. 9, 2033 | A METHOD FOR TREATING ACNE IN INFLAMMATORY LESIONS OF NON-NODULAR MODERATE TO SEVERE ACNE VULGARIS PATIENTS 9 YEARS OF AGE AND OLDER COMPRISING ADMINISTERING AN EFFECTIVE AMOUNT OF SARECYCLINE HYDROCHLORIDE CRYSTALLINE SALT |
EQ 150MG BASE | SEYSARA | ALMIRALL | N209521 | Oct. 1, 2018 | RX | TABLET | ORAL | 9255068 | Feb. 9, 2033 | A METHOD FOR TREATING A BACTERIAL INFECTION IN INFLAMMATORY LESIONS OF NON-NODULAR MODERATE TO SEVERE ACNE VULGARIS PATIENTS 9 YEARS OF AGE AND OLDER COMPRISING ADMINISTERING AN EFFECTIVE AMOUNT OF SARECYCLINE HYDROCHLORIDE CRYSTALLINE SALT |
EQ 150MG BASE | SEYSARA | ALMIRALL | N209521 | Oct. 1, 2018 | RX | TABLET | ORAL | 9255068 | Feb. 9, 2033 | A METHOD FOR TREATING ACNE IN INFLAMMATORY LESIONS OF NON-NODULAR MODERATE TO SEVERE ACNE VULGARIS PATIENTS 9 YEARS OF AGE AND OLDER COMPRISING ADMINISTERING AN EFFECTIVE AMOUNT OF SARECYCLINE HYDROCHLORIDE CRYSTALLINE SALT |
EQ 60MG BASE | SEYSARA | ALMIRALL | N209521 | Oct. 1, 2018 | RX | TABLET | ORAL | 9255068 | Feb. 9, 2033 | A METHOD FOR TREATING A BACTERIAL INFECTION IN INFLAMMATORY LESIONS OF NON-NODULAR MODERATE TO SEVERE ACNE VULGARIS PATIENTS 9 YEARS OF AGE AND OLDER COMPRISING ADMINISTERING AN EFFECTIVE AMOUNT OF SARECYCLINE HYDROCHLORIDE CRYSTALLINE SALT |
EQ 60MG BASE | SEYSARA | ALMIRALL | N209521 | Oct. 1, 2018 | RX | TABLET | ORAL | 9255068 | Feb. 9, 2033 | A METHOD FOR TREATING ACNE IN INFLAMMATORY LESIONS OF NON-NODULAR MODERATE TO SEVERE ACNE VULGARIS PATIENTS 9 YEARS OF AGE AND OLDER COMPRISING ADMINISTERING AN EFFECTIVE AMOUNT OF SARECYCLINE HYDROCHLORIDE CRYSTALLINE SALT |
Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
---|---|---|---|---|---|---|---|---|---|
EQ 100MG BASE | SEYSARA | ALMIRALL | N209521 | Oct. 1, 2018 | RX | TABLET | ORAL | Oct. 1, 2023 | NEW CHEMICAL ENTITY |
EQ 150MG BASE | SEYSARA | ALMIRALL | N209521 | Oct. 1, 2018 | RX | TABLET | ORAL | Oct. 1, 2023 | NEW CHEMICAL ENTITY |
EQ 60MG BASE | SEYSARA | ALMIRALL | N209521 | Oct. 1, 2018 | RX | TABLET | ORAL | Oct. 1, 2023 | NEW CHEMICAL ENTITY |
None
ID | Source |
---|---|
94O110CX2E | UNII |
C4519292 | UMLSCUI |
V7A | PDB_CHEM_ID |
CHEMBL2364632 | ChEMBL_ID |
54681908 | PUBCHEM_CID |
DB12035 | DRUGBANK_ID |
CHEMBL2364633 | ChEMBL_ID |
D10666 | KEGG_DRUG |
2059018 | RXNORM |
294179 | MMSL |
35296 | MMSL |
d09003 | MMSL |
781643008 | SNOMEDCT_US |
781650007 | SNOMEDCT_US |
4038062 | VANDF |
017779 | NDDF |
017780 | NDDF |
C000629276 | MESH_SUPPLEMENTAL_RECORD_UI |
9743 | INN_ID |
1035979-44-2 | SECONDARY_CAS_RN |
Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
---|---|---|---|---|---|---|---|---|
Seysara | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16110-245 | TABLET, COATED | 60 mg | ORAL | NDA | 29 sections |
Seysara | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16110-246 | TABLET, COATED | 100 mg | ORAL | NDA | 29 sections |
Seysara | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16110-247 | TABLET, COATED | 150 mg | ORAL | NDA | 29 sections |