Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
TAGI Pharma, Inc
963322560
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Elite Laboratories, Inc.
TAGI Pharma, Inc
TAGI Pharma, Inc
785398728
Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Phentermine Hydrochloride
Product Details
NDC Product Code
51224-203Application Number
ANDA202248Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
May 31, 2019LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
Code: 0K2I505OTVClass: ACTIBQuantity: 15 mg in 1 1
STARCH, TAPIOCAInactive
Code: 24SC3U704IClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQYClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
Phentermine Hydrochloride
Product Details
NDC Product Code
51224-202Application Number
ANDA202248Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
May 31, 2019Code: 0K2I505OTVClass: ACTIBQuantity: 30 mg in 1 1
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
STARCH, TAPIOCAInactive
Code: 24SC3U704IClass: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQYClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT