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FDA Approval

Temozolomide

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

FDA Approval Summary

Company
Ascend Laboratories, LLC
DUNS: 141250469
Effective Date
March 28, 2023
Labeling Type
Human Prescription Drug Label
Temozolomide(20 mg in 1 1)

Manufacturing Establishments1

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

Deva Holding A.S

Ascend Laboratories, LLC

502664395

Products6

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

Temozolomide

Product Details

NDC Product Code
67877-538
Application Number
ANDA207658
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
February 15, 2023
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
TemozolomideActive
Code: YF1K15M17YClass: ACTIBQuantity: 20 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
TARTARIC ACIDInactive
Code: W4888I119HClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT

Temozolomide

Product Details

NDC Product Code
67877-542
Application Number
ANDA207658
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
February 15, 2023
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
TemozolomideActive
Code: YF1K15M17YClass: ACTIBQuantity: 250 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
TARTARIC ACIDInactive
Code: W4888I119HClass: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT

Temozolomide

Product Details

NDC Product Code
67877-540
Application Number
ANDA207658
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
February 15, 2023
TemozolomideActive
Code: YF1K15M17YClass: ACTIBQuantity: 140 mg in 1 1
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
TARTARIC ACIDInactive
Code: W4888I119HClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT

Temozolomide

Product Details

NDC Product Code
67877-539
Application Number
ANDA207658
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
February 15, 2023
TemozolomideActive
Code: YF1K15M17YClass: ACTIBQuantity: 100 mg in 1 1
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
TARTARIC ACIDInactive
Code: W4888I119HClass: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT

Temozolomide

Product Details

NDC Product Code
67877-541
Application Number
ANDA207658
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
February 15, 2023
TARTARIC ACIDInactive
Code: W4888I119HClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
TemozolomideActive
Code: YF1K15M17YClass: ACTIBQuantity: 180 mg in 1 1
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT

Temozolomide

Product Details

NDC Product Code
67877-537
Application Number
ANDA207658
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
February 15, 2023
TemozolomideActive
Code: YF1K15M17YClass: ACTIBQuantity: 5 mg in 1 1
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
TARTARIC ACIDInactive
Code: W4888I119HClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
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