MedPath
FDA Approval

Risedronate Sodium

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

FDA Approval Summary

Company
Effective Date
September 27, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL

Registrants1

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

Zydus Lifesciences Limited

918596198

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Zydus Lifesciences Limited

Zydus Lifesciences Limited

Zydus Lifesciences Limited

918596198

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
70771-1436
Application Number
ANDA203822
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
September 27, 2023
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive
Code: NX76LV5T8JClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UMClass: IACT
Code: OFG5EXG60LClass: ACTIBQuantity: 35 mg in 1 1

Drug Labeling Information

Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1436-4 in blister-carton of 4 (1 x 4) Unit-dose Tablets

Risedronate Sodium Delayed-release Tablets, 35 mg

Rx only

4 Tablets

Risedronate Sodium DR Tablets, 35 mg

Risedronate Sodium DR Tablets, 35 mg

Risedronate Sodium DR Tablets, 35 mg


© Copyright 2025. All Rights Reserved by MedPath