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FDA Approval

Leucovorin Calcium

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

FDA Approval Summary

Company
Ingenus Pharmaceuticals, LLC
DUNS: 833250017
Effective Date
December 8, 2020
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Leucovorin(25 mg in 1 1)

Registrants1

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

Novast Laboratories, Ltd.

527695995

Manufacturing Establishments1

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

Ingenus Pharmaceuticals NJ, LLC

Ingenus Pharmaceuticals, LLC

Novast Laboratories, Ltd.

964680206

Products4

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

Leucovorin Calcium

Product Details

NDC Product Code
50742-184
Application Number
ANDA211132
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
August 7, 2020
LeucovorinActive
Code: RPR1R4C0P4Class: ACTIMQuantity: 25 mg in 1 1
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT

Leucovorin Calcium

Product Details

NDC Product Code
50742-181
Application Number
ANDA211132
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
August 7, 2020
LeucovorinActive
Code: RPR1R4C0P4Class: ACTIMQuantity: 5 mg in 1 1
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT

Leucovorin Calcium

Product Details

NDC Product Code
50742-183
Application Number
ANDA211132
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
August 7, 2020
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
LeucovorinActive
Code: RPR1R4C0P4Class: ACTIMQuantity: 15 mg in 1 1
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT

Leucovorin Calcium

Product Details

NDC Product Code
50742-182
Application Number
ANDA211132
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
August 7, 2020
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
LeucovorinActive
Code: RPR1R4C0P4Class: ACTIMQuantity: 10 mg in 1 1
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
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