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FDA Approval

Senna Plus

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
March 24, 2025
Labeling Type
HUMAN OTC DRUG LABEL
Sennosides(8.6 mg in 1 1)
Docusate(50 mg in 1 1)

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

Geri-Care Pharmaceutical Corp

611196254

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Senna Plus

Product Details

NDC Product Code
57896-458
Application Number
505G(a)(3)
Marketing Category
OTC Monograph Drug (C200263)
Route of Administration
ORAL
Effective Date
March 24, 2025
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: L11K75P92JClass: IACT
MAGNESIUM SILICATEInactive
Code: 9B9691B2N9Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MINERAL OILInactive
Code: T5L8T28FGPClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
FD&C YELLOW NO. 5Inactive
Code: I753WB2F1MClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EUClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
Code: 3FYP5M0IJXClass: ACTIBQuantity: 8.6 mg in 1 1
DocusateActive
Code: F05Q2T2JA0Class: ACTIBQuantity: 50 mg in 1 1
CARNAUBA WAXInactive
Code: R12CBM0EIZClass: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
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