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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 050805


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NDA 050805 describes ORACEA, which is a drug marketed by Galderma Labs Lp and is included in one NDA. It is available from three suppliers. There are six patents protecting this drug and one Paragraph IV challenge. Additional details are available on the ORACEA profile page.

The generic ingredient in ORACEA is doxycycline. There are twenty-eight drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the doxycycline profile page.
Summary for 050805
Tradename:ORACEA
Applicant:Galderma Labs Lp
Ingredient:doxycycline
Patents:6
Formulation / Manufacturing:see details
Pharmacology for NDA: 050805
Medical Subject Heading (MeSH) Categories for 050805
Suppliers and Packaging for NDA: 050805
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ORACEA doxycycline CAPSULE;ORAL 050805 NDA Galderma Laboratories, L.P. 0299-3822 0299-3822-02 12 TRAY in 1 BOX (0299-3822-02) / 8 CARTON in 1 TRAY / 1 BLISTER PACK in 1 CARTON / 2 CAPSULE in 1 BLISTER PACK
ORACEA doxycycline CAPSULE;ORAL 050805 NDA Galderma Laboratories, L.P. 0299-3822 0299-3822-04 4 CAPSULE in 1 BLISTER PACK (0299-3822-04)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength40MG
Approval Date:May 26, 2006TE:RLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Dec 19, 2027Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF ONLY INFLAMMATORY LESIONS (PAPULES AND PUSTULES) OF ROSACEA
Patent:⤷  Try a TrialPatent Expiration:Dec 24, 2025Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF ONLY INFLAMMATORY LESIONS (PAPULES AND PUSTULES) OF ROSACEA
Patent:⤷  Try a TrialPatent Expiration:Apr 7, 2024Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF ONLY INFLAMMATORY LESIONS (PAPULES AND PUSTULES) OF ROSACEA

Expired US Patents for NDA 050805

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Galderma Labs Lp ORACEA doxycycline CAPSULE;ORAL 050805-001 May 26, 2006 ⤷  Try a Trial ⤷  Try a Trial
Galderma Labs Lp ORACEA doxycycline CAPSULE;ORAL 050805-001 May 26, 2006 ⤷  Try a Trial ⤷  Try a Trial
Galderma Labs Lp ORACEA doxycycline CAPSULE;ORAL 050805-001 May 26, 2006 ⤷  Try a Trial ⤷  Try a Trial
Galderma Labs Lp ORACEA doxycycline CAPSULE;ORAL 050805-001 May 26, 2006 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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