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Last Updated: July 7, 2020

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Details for New Drug Application (NDA): 050641

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NDA 050641 describes MONODOX, which is a drug marketed by Almirall and is included in one NDA. It is available from two suppliers. Additional details are available on the MONODOX profile page.

The generic ingredient in MONODOX is doxycycline. There are twenty-eight drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the doxycycline profile page.
Summary for 050641
Formulation / Manufacturing:see details
Pharmacology for NDA: 050641
Medical Subject Heading (MeSH) Categories for 050641
Suppliers and Packaging for NDA: 050641
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MONODOX doxycycline CAPSULE;ORAL 050641 NDA Aqua Pharmaceuticals, LLC 16110-075 16110-075-01 100 CAPSULE in 1 BOTTLE (16110-075-01)
MONODOX doxycycline CAPSULE;ORAL 050641 NDA Aqua Pharmaceuticals, LLC 16110-259 16110-259-04 50 CAPSULE in 1 BOTTLE (16110-259-04)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrengthEQ 100MG BASE
Approval Date:Dec 29, 1989TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrengthEQ 50MG BASE
Approval Date:Feb 10, 1992TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrengthEQ 75MG BASE
Approval Date:Oct 18, 2006TE:RLD:Yes

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