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FDA Approval

PRAVASTATIN SODIUM

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

FDA Approval Summary

Company

Lupin Pharmaceuticals, Inc.

DUNS: 089153071

Effective Date

December 19, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Pravastatin(80 mg in 1 1)

Registrants1

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

DUNS Number

675923163

Manufacturing Establishments1

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

Labeler

Lupin Pharmaceuticals, Inc.

Registrant

LUPIN LIMITED

DUNS Number

677600414

Products4

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

PRAVASTATIN SODIUM

Product Details

NDC Product Code

68180-488

Application Number

ANDA077917

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 19, 2023

Ingredients

PravastatinActive

Code: 3M8608UQ61Class: ACTIBQuantity: 80 mg in 1 1

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

SODIUM BICARBONATEInactive

Code: 8MDF5V39QOClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

POLYETHYLENE GLYCOL 8000Inactive

Code: Q662QK8M3BClass: IACT

HYPROMELLOSE 2910 (6 MPA.S)Inactive

Code: 0WZ8WG20P6Class: IACT

CROSPOVIDONE (15 MPA.S AT 5%)Inactive

Code: 68401960MKClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

PRAVASTATIN SODIUM

Product Details

NDC Product Code

68180-487

Application Number

ANDA077917

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 19, 2023

Ingredients

PravastatinActive

Code: 3M8608UQ61Class: ACTIBQuantity: 40 mg in 1 1

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

SODIUM BICARBONATEInactive

Code: 8MDF5V39QOClass: IACT

HYPROMELLOSE 2910 (6 MPA.S)Inactive

Code: 0WZ8WG20P6Class: IACT

POLYETHYLENE GLYCOL 8000Inactive

Code: Q662QK8M3BClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

CROSPOVIDONE (15 MPA.S AT 5%)Inactive

Code: 68401960MKClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

PRAVASTATIN SODIUM

Product Details

NDC Product Code

68180-486

Application Number

ANDA077917

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 19, 2023

Ingredients

PravastatinActive

Code: 3M8608UQ61Class: ACTIBQuantity: 20 mg in 1 1

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

SODIUM BICARBONATEInactive

Code: 8MDF5V39QOClass: IACT

POLYETHYLENE GLYCOL 6000Inactive

Code: 30IQX730WEClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

CROSPOVIDONE (15 MPA.S AT 5%)Inactive

Code: 68401960MKClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

HYPROMELLOSE 2910 (6 MPA.S)Inactive

Code: 0WZ8WG20P6Class: IACT

PRAVASTATIN SODIUM

Product Details

NDC Product Code

68180-485

Application Number

ANDA077917

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 19, 2023

Ingredients

PravastatinActive

Code: 3M8608UQ61Class: ACTIBQuantity: 10 mg in 1 1

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

SODIUM BICARBONATEInactive

Code: 8MDF5V39QOClass: IACT

HYPROMELLOSE 2910 (6 MPA.S)Inactive

Code: 0WZ8WG20P6Class: IACT

POLYETHYLENE GLYCOL 8000Inactive

Code: Q662QK8M3BClass: IACT

CROSPOVIDONE (15 MPA.S AT 5%)Inactive

Code: 68401960MKClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

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