Salagen
SALAGEN Tablets (pilocarpine hydrochloride)
Approved
Approval ID
62eda83d-d043-4c7e-8fcf-75d05efbf35b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 11, 2022
Manufacturers
FDA
Concordia Pharmaceuticals Inc.
DUNS: 815240092
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Pilocarpine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59212-705
Application NumberNDA020237
Product Classification
M
Marketing Category
C73594
G
Generic Name
Pilocarpine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 11, 2022
FDA Product Classification
INGREDIENTS (7)
PILOCARPINE HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: 0WW6D218XJ
Classification: ACTIB
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
Pilocarpine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59212-775
Application NumberNDA020237
Product Classification
M
Marketing Category
C73594
G
Generic Name
Pilocarpine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 11, 2022
FDA Product Classification
INGREDIENTS (8)
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
PILOCARPINE HYDROCHLORIDEActive
Quantity: 7.5 mg in 1 1
Code: 0WW6D218XJ
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
FD&C BLUE NO. 2--ALUMINUM LAKEInactive
Code: 4AQJ3LG584
Classification: IACT