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FDA Approval

Norpace

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

FDA Approval Summary

Company
Pfizer Laboratories Div Pfizer Inc
DUNS: 134489525
Effective Date
August 30, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Disopyramide(150 mg in 1 1)

Products4

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

Norpace

Product Details

NDC Product Code
0025-2762
Application Number
NDA017447
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
August 30, 2023
Code: N6BOM1935WClass: ACTIMQuantity: 150 mg in 1 1
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQYClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98GClass: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT

Norpace

Product Details

NDC Product Code
0025-2752
Application Number
NDA017447
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
August 30, 2023
Code: N6BOM1935WClass: ACTIMQuantity: 100 mg in 1 1
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQYClass: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98GClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT

Norpace CR

Product Details

NDC Product Code
0025-2732
Application Number
NDA018655
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
August 30, 2023
Code: N6BOM1935WClass: ACTIMQuantity: 100 mg in 1 1
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
ETHYLCELLULOSE, UNSPECIFIEDInactive
Code: 7Z8S9VYZ4BClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT

Norpace CR

Product Details

NDC Product Code
0025-2742
Application Number
NDA018655
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
August 30, 2023
Code: N6BOM1935WClass: ACTIMQuantity: 150 mg in 1 1
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
ETHYLCELLULOSE, UNSPECIFIEDInactive
Code: 7Z8S9VYZ4BClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQYClass: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
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