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FDA Approval

olanzapine

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

FDA Approval Summary

Company
Zydus Lifesciences Limited
DUNS: 918596198
Effective Date
September 27, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Olanzapine(7.5 mg in 1 1)

Registrants1

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

Zydus Lifesciences Limited

918596198

Manufacturing Establishments1

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

Zydus Lifesciences Limited

Zydus Lifesciences Limited

Zydus Lifesciences Limited

918596198

Products6

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

olanzapine

Product Details

NDC Product Code
70771-1418
Application Number
ANDA090459
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
September 27, 2023
OlanzapineActive
Code: N7U69T4SZRClass: ACTIBQuantity: 7.5 mg in 1 1
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
XANTHAN GUMInactive
Code: TTV12P4NEEClass: IACT

olanzapine

Product Details

NDC Product Code
70771-1419
Application Number
ANDA090459
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
September 27, 2023
OlanzapineActive
Code: N7U69T4SZRClass: ACTIBQuantity: 10 mg in 1 1
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62Class: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
XANTHAN GUMInactive
Code: TTV12P4NEEClass: IACT

olanzapine

Product Details

NDC Product Code
70771-1417
Application Number
ANDA090459
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
September 27, 2023
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
OlanzapineActive
Code: N7U69T4SZRClass: ACTIBQuantity: 5 mg in 1 1
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
XANTHAN GUMInactive
Code: TTV12P4NEEClass: IACT

olanzapine

Product Details

NDC Product Code
70771-1416
Application Number
ANDA090459
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
September 27, 2023
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
OlanzapineActive
Code: N7U69T4SZRClass: ACTIBQuantity: 2.5 mg in 1 1
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
XANTHAN GUMInactive
Code: TTV12P4NEEClass: IACT

olanzapine

Product Details

NDC Product Code
70771-1421
Application Number
ANDA090459
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
September 27, 2023
OlanzapineActive
Code: N7U69T4SZRClass: ACTIBQuantity: 20 mg in 1 1
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
XANTHAN GUMInactive
Code: TTV12P4NEEClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT

olanzapine

Product Details

NDC Product Code
70771-1420
Application Number
ANDA090459
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
September 27, 2023
OlanzapineActive
Code: N7U69T4SZRClass: ACTIBQuantity: 15 mg in 1 1
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
XANTHAN GUMInactive
Code: TTV12P4NEEClass: IACT
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