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FDA Approval

PHENDIMETRAZINE TARTRATE

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

FDA Approval Summary

Company
Effective Date
February 6, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Phendimetrazine(105 mg in 1 1)

Manufacturing Establishments1

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

A-S Medication Solutions

A-S Medication Solutions

830016429

Products1

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

PHENDIMETRAZINE TARTRATE

Product Details

NDC Product Code
50090-3988
Application Number
NDA018074
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
October 10, 2022
Code: 6985IP0T80Class: ACTIBQuantity: 105 mg in 1 1
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94EClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
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