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Details for New Drug Application (NDA): 204683

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NDA 204683 describes KHEDEZLA, which is a drug marketed by Osmotica Pharm Corp and is included in one NDA. It is available from two suppliers. Additional details are available on the KHEDEZLA profile page.

The generic ingredient in KHEDEZLA is desvenlafaxine. There are fourteen drug master file entries for this compound. Three suppliers are listed for this compound. There are two tentative approvals for this compound. Additional details are available on the desvenlafaxine profile page.

Summary for NDA: 204683

Tradename:
KHEDEZLA
Applicant:
Osmotica Pharm Corp
Ingredient:
desvenlafaxine
Patents:0
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 204683

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
KHEDEZLA
desvenlafaxine
TABLET, EXTENDED RELEASE;ORAL 204683 NDA AUTHORIZED GENERIC Macoven Pharmaceuticals 44183-880 44183-880-31 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (44183-880-31)
KHEDEZLA
desvenlafaxine
TABLET, EXTENDED RELEASE;ORAL 204683 NDA AUTHORIZED GENERIC Macoven Pharmaceuticals 44183-880 44183-880-90 90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (44183-880-90)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength50MG
Approval Date:Jul 10, 2013TE:BCRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength100MG
Approval Date:Jul 10, 2013TE:BCRLD:No


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