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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

Teva Pharmaceuticals USA, Inc.

DUNS: 001627975

Effective Date

January 31, 2022

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Colecalciferol/Risedronate Sodium(30 mg in 1 1)

Products3

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

0093-3100

Application Number

ANDA077132

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 31, 2022

Ingredients

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

HYPROMELLOSE 2910 (5 MPA.S)Inactive

Code: R75537T0T4Class: IACT

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQClass: IACT

HYPROMELLOSE 2910 (3 MPA.S)Inactive

Code: 0VUT3PMY82Class: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8HClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

SODIUM STEARYL FUMARATEInactive

Code: 7CV7WJK4UIClass: IACT

Colecalciferol/Risedronate SodiumActive

Code: F67L43UT5CClass: ACTIRQuantity: 30 mg in 1 1

Risedronate Sodium

Product Details

NDC Product Code

0093-3098

Application Number

ANDA077132

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 31, 2022

Ingredients

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

HYPROMELLOSE 2910 (3 MPA.S)Inactive

Code: 0VUT3PMY82Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

HYPROMELLOSE 2910 (5 MPA.S)Inactive

Code: R75537T0T4Class: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

SODIUM STEARYL FUMARATEInactive

Code: 7CV7WJK4UIClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8Class: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8HClass: IACT

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQClass: IACT

Colecalciferol/Risedronate SodiumActive

Code: F67L43UT5CClass: ACTIRQuantity: 35 mg in 1 1

Risedronate Sodium

Product Details

NDC Product Code

0093-3099

Application Number

ANDA077132

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 31, 2022

Ingredients

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

HYPROMELLOSE 2910 (5 MPA.S)Inactive

Code: R75537T0T4Class: IACT

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

HYPROMELLOSE 2910 (3 MPA.S)Inactive

Code: 0VUT3PMY82Class: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

SODIUM STEARYL FUMARATEInactive

Code: 7CV7WJK4UIClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8HClass: IACT

Colecalciferol/Risedronate SodiumActive

Code: F67L43UT5CClass: ACTIRQuantity: 5 mg in 1 1

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