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FDA Approval

Risedronate Sodium

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

FDA Approval Summary

Company
Greenstone LLC
DUNS: 825560733
Effective Date
October 1, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL

Products1

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

Risedronate Sodium

Product Details

NDC Product Code
59762-0407
Application Number
NDA022560
Marketing Category
NDA authorized generic (C73605)
Route of Administration
ORAL
Effective Date
December 29, 2023
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACT
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive
Code: NX76LV5T8JClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UMClass: IACT
Code: F67L43UT5CClass: ACTIRQuantity: 4.9 mg in 1 1
Code: HU2YAQ274OClass: ACTIRQuantity: 30.1 mg in 1 1
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