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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
KVK-TECH, INC
DUNS: 173360061
Effective Date
December 11, 2019
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Phendimetrazine(35 mg in 1 1)

Registrants1

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

KVK-TECH, INC.

173360061

Manufacturing Establishments1

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

KVK-TECH, INC

KVK-TECH, INC

KVK-TECH, INC.

173360061

Products3

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
10702-077
Application Number
ANDA091042
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
December 11, 2019
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
FD&C YELLOW NO. 5Inactive
Code: I753WB2F1MClass: IACT
PhendimetrazineActive
Code: 6985IP0T80Class: ACTIBQuantity: 35 mg in 1 1

Phendimetrazine Tartrate

Product Details

NDC Product Code
10702-045
Application Number
ANDA091042
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
December 11, 2019
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
PhendimetrazineActive
Code: 6985IP0T80Class: ACTIBQuantity: 35 mg in 1 1

Phendimetrazine Tartrate

Product Details

NDC Product Code
10702-078
Application Number
ANDA091042
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
December 11, 2019
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
PhendimetrazineActive
Code: 6985IP0T80Class: ACTIBQuantity: 35 mg in 1 1
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
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