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FDA Approval

CLOMIPRAMINE HYDROCHLORIDE

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

FDA Approval Summary

Company

Alembic Pharmaceuticals Limited

DUNS: 650574663

Effective Date

January 27, 2023

Labeling Type

Human Prescription Drug Label

Active Ingredients

Clomipramine(50 mg in 1 1)

Manufacturing Establishments1

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

Alembic Pharmaceuticals Limited

Labeler

Alembic Pharmaceuticals Limited

DUNS Number

650574671

Products3

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

CLOMIPRAMINE HYDROCHLORIDE

Product Details

NDC Product Code

46708-408

Application Number

ANDA211822

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 27, 2023

Ingredients

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

ClomipramineActive

Code: 2LXW0L6GWJClass: ACTIBQuantity: 50 mg in 1 1

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8Class: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

CLOMIPRAMINE HYDROCHLORIDE

Product Details

NDC Product Code

46708-409

Application Number

ANDA211822

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 27, 2023

Ingredients

ClomipramineActive

Code: 2LXW0L6GWJClass: ACTIBQuantity: 75 mg in 1 1

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8Class: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

CLOMIPRAMINE HYDROCHLORIDE

Product Details

NDC Product Code

46708-407

Application Number

ANDA211822

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 27, 2023

Ingredients

ClomipramineActive

Code: 2LXW0L6GWJClass: ACTIBQuantity: 25 mg in 1 1

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8Class: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

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