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FDA Approval

Saxagliptin and Metformin Hydrochloride

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

FDA Approval Summary

Company

Dr.Reddys Laboratories Inc

DUNS: 802315887

Effective Date

July 28, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Saxagliptin(5 mg in 1 1)

Metformin(1000 mg in 1 1)

Manufacturing Establishments1

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

Dr. Reddys Laboratories Limited (SEZ UNIT)

Labeler

Dr.Reddys Laboratories Inc

DUNS Number

860037244

Products3

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

Saxagliptin and Metformin Hydrochloride

Product Details

NDC Product Code

43598-619

Application Number

ANDA207678

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

July 28, 2023

Ingredients

SaxagliptinActive

Code: 9GB927LAJWClass: ACTIMQuantity: 5 mg in 1 1

MetforminActive

Code: 786Z46389EClass: ACTIBQuantity: 1000 mg in 1 1

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

HYDROCHLORIC ACIDInactive

Code: QTT17582CBClass: IACT

HYPROMELLOSE 2208 (100000 MPA.S)Inactive

Code: VM7F0B23ZIClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQClass: IACT

HYPROMELLOSE 2910 (6 MPA.S)Inactive

Code: 0WZ8WG20P6Class: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

POLYETHYLENE GLYCOL 3350Inactive

Code: G2M7P15E5PClass: IACT

POLYETHYLENE GLYCOL 4000Inactive

Code: 4R4HFI6D95Class: IACT

POLYETHYLENE GLYCOL 8000Inactive

Code: Q662QK8M3BClass: IACT

POVIDONE K30Inactive

Code: U725QWY32XClass: IACT

POVIDONE K90Inactive

Code: RDH86HJV5ZClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

Saxagliptin and Metformin Hydrochloride

Product Details

NDC Product Code

43598-620

Application Number

ANDA207678

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

July 28, 2023

Ingredients

HYPROMELLOSE 2208 (100000 MPA.S)Inactive

Code: VM7F0B23ZIClass: IACT

HYDROCHLORIC ACIDInactive

Code: QTT17582CBClass: IACT

SaxagliptinActive

Code: 9GB927LAJWClass: ACTIMQuantity: 5 mg in 1 1

MetforminActive

Code: 786Z46389EClass: ACTIBQuantity: 500 mg in 1 1

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

HYPROMELLOSE 2910 (6 MPA.S)Inactive

Code: 0WZ8WG20P6Class: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

POLYETHYLENE GLYCOL 8000Inactive

Code: Q662QK8M3BClass: IACT

POVIDONE K30Inactive

Code: U725QWY32XClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

POLYETHYLENE GLYCOL 3350Inactive

Code: G2M7P15E5PClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

POLYETHYLENE GLYCOL 4000Inactive

Code: 4R4HFI6D95Class: IACT

POVIDONE K90Inactive

Code: RDH86HJV5ZClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

Saxagliptin and Metformin Hydrochloride

Product Details

NDC Product Code

43598-618

Application Number

ANDA207678

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

July 28, 2023

Ingredients

SaxagliptinActive

Code: 9GB927LAJWClass: ACTIMQuantity: 2.5 mg in 1 1

MetforminActive

Code: 786Z46389EClass: ACTIBQuantity: 1000 mg in 1 1

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

HYDROCHLORIC ACIDInactive

Code: QTT17582CBClass: IACT

HYPROMELLOSE 2208 (100000 MPA.S)Inactive

Code: VM7F0B23ZIClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

HYPROMELLOSE 2910 (6 MPA.S)Inactive

Code: 0WZ8WG20P6Class: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

POLYETHYLENE GLYCOL 3350Inactive

Code: G2M7P15E5PClass: IACT

POLYETHYLENE GLYCOL 4000Inactive

Code: 4R4HFI6D95Class: IACT

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQClass: IACT

POVIDONE K30Inactive

Code: U725QWY32XClass: IACT

POLYETHYLENE GLYCOL 8000Inactive

Code: Q662QK8M3BClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

POVIDONE K90Inactive

Code: RDH86HJV5ZClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

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