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Details for New Drug Application (NDA): 040872

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NDA 040872 describes PHENTERMINE RESIN COMPLEX, which is a drug marketed by Lannett Holdings Inc and is included in one NDA. It is available from one supplier. Additional details are available on the PHENTERMINE RESIN COMPLEX profile page.

The generic ingredient in PHENTERMINE RESIN COMPLEX is phentermine resin complex. There are seventeen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the phentermine resin complex profile page.

Summary for NDA: 040872

Tradename:
PHENTERMINE RESIN COMPLEX
Applicant:
Lannett Holdings Inc
Ingredient:
phentermine resin complex
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 040872

Suppliers and Packaging for NDA: 040872

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PHENTERMINE RESIN COMPLEX
phentermine resin complex
CAPSULE, EXTENDED RELEASE;ORAL 040872 ANDA Lannett Company, Inc. 0527-1366 0527-1366-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0527-1366-01)
PHENTERMINE RESIN COMPLEX
phentermine resin complex
CAPSULE, EXTENDED RELEASE;ORAL 040872 ANDA Lannett Company, Inc. 0527-1398 0527-1398-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0527-1398-01)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE, EXTENDED RELEASE;ORALStrengthEQ 15MG BASE
Approval Date:Jul 28, 2011TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE, EXTENDED RELEASE;ORALStrengthEQ 30MG BASE
Approval Date:Jul 28, 2011TE:RLD:No


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