MedPath
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 11, 2021
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Phendimetrazine(35 mg in 1 1)

Manufacturing Establishments1

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

NuCare Pharmaceuticals, Inc.

NuCare Pharmaceuticals, Inc.

010632300

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
68071-3062
Application Number
ANDA085588
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
February 11, 2021
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
FD&C YELLOW NO. 5Inactive
Code: I753WB2F1MClass: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94EClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
Code: 6985IP0T80Class: ACTIBQuantity: 35 mg in 1 1
© Copyright 2025. All Rights Reserved by MedPath