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FDA Approval

Sertraline Hydrochloride

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

FDA Approval Summary

Company

Ranbaxy Pharmaceuticals Inc.

DUNS: 937890044

Effective Date

January 7, 2016

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Sertraline(150 mg in 1 1)

Registrants1

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

Ranbaxy Pharmaceuticals Inc.

DUNS Number

937890044

Manufacturing Establishments1

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

Ohm Laboratories Inc.

Labeler

Ranbaxy Pharmaceuticals Inc.

Registrant

Ranbaxy Pharmaceuticals Inc.

DUNS Number

051565745

Products5

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

Sertraline Hydrochloride

Product Details

NDC Product Code

63304-167

Application Number

ANDA077977

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

October 9, 2014

Ingredients

SertralineActive

Code: UTI8907Y6XClass: ACTIMQuantity: 150 mg in 1 1

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEInactive

Code: O7TSZ97GEPClass: IACT

HYDROXYPROPYL CELLULOSE (TYPE H)Inactive

Code: RFW2ET671PClass: IACT

POLYETHYLENE GLYCOLSInactive

Code: 3WJQ0SDW1AClass: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive

Code: 5856J3G2A2Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

Sertraline Hydrochloride

Product Details

NDC Product Code

63304-164

Application Number

ANDA077977

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

October 9, 2014

Ingredients

HYDROXYPROPYL CELLULOSE (TYPE H)Inactive

Code: RFW2ET671PClass: IACT

SertralineActive

Code: UTI8907Y6XClass: ACTIMQuantity: 25 mg in 1 1

CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEInactive

Code: O7TSZ97GEPClass: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

POLYETHYLENE GLYCOLSInactive

Code: 3WJQ0SDW1AClass: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive

Code: 5856J3G2A2Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

Sertraline Hydrochloride

Product Details

NDC Product Code

63304-168

Application Number

ANDA077977

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

October 9, 2014

Ingredients

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

SertralineActive

Code: UTI8907Y6XClass: ACTIMQuantity: 200 mg in 1 1

CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEInactive

Code: O7TSZ97GEPClass: IACT

HYDROXYPROPYL CELLULOSE (TYPE H)Inactive

Code: RFW2ET671PClass: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

POLYETHYLENE GLYCOLSInactive

Code: 3WJQ0SDW1AClass: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive

Code: 5856J3G2A2Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

Sertraline Hydrochloride

Product Details

NDC Product Code

63304-166

Application Number

ANDA077977

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

October 9, 2014

Ingredients

CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEInactive

Code: O7TSZ97GEPClass: IACT

SertralineActive

Code: UTI8907Y6XClass: ACTIMQuantity: 100 mg in 1 1

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

HYDROXYPROPYL CELLULOSE (TYPE H)Inactive

Code: RFW2ET671PClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

POLYETHYLENE GLYCOLSInactive

Code: 3WJQ0SDW1AClass: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive

Code: 5856J3G2A2Class: IACT

Sertraline Hydrochloride

Product Details

NDC Product Code

63304-165

Application Number

ANDA077977

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

October 9, 2014

Ingredients

CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEInactive

Code: O7TSZ97GEPClass: IACT

SertralineActive

Code: UTI8907Y6XClass: ACTIMQuantity: 50 mg in 1 1

HYDROXYPROPYL CELLULOSE (TYPE H)Inactive

Code: RFW2ET671PClass: IACT

POLYETHYLENE GLYCOLSInactive

Code: 3WJQ0SDW1AClass: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive

Code: 5856J3G2A2Class: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

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