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FDA Approval

Metformin Hydrochloride

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

FDA Approval Summary

Company

Laurus Labs Limited

DUNS: 915075687

Effective Date

September 21, 2023

Labeling Type

Human Prescription Drug Label

Active Ingredients

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.

Laurus Labs Limited (VSP2)

Labeler

Laurus Labs Limited

DUNS Number

650885309

Products3

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

Metformin Hydrochloride

Product Details

NDC Product Code

42385-949

Application Number

ANDA209882

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

September 21, 2023

Ingredients

MetforminActive

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

POVIDONE K30Inactive

Code: U725QWY32XClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

HYPROMELLOSE 2910 (6 MPA.S)Inactive

Code: 0WZ8WG20P6Class: IACT

POLYETHYLENE GLYCOL 3350Inactive

Code: G2M7P15E5PClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

Metformin Hydrochloride

Product Details

NDC Product Code

42385-948

Application Number

ANDA209882

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

September 21, 2023

Ingredients

MetforminActive

Code: 786Z46389EClass: ACTIBQuantity: 850 mg in 1 1

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

POVIDONE K30Inactive

Code: U725QWY32XClass: IACT

HYPROMELLOSE 2910 (6 MPA.S)Inactive

Code: 0WZ8WG20P6Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

POLYETHYLENE GLYCOL 3350Inactive

Code: G2M7P15E5PClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

Metformin Hydrochloride

Product Details

NDC Product Code

42385-947

Application Number

ANDA209882

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

September 21, 2023

Ingredients

MetforminActive

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

HYPROMELLOSE 2910 (6 MPA.S)Inactive

Code: 0WZ8WG20P6Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

POVIDONE K30Inactive

Code: U725QWY32XClass: IACT

POLYETHYLENE GLYCOL 3350Inactive

Code: G2M7P15E5PClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

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