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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 four suppliers. There are twelve 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-seven drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. There are four tentative approvals for this compound. Additional details are available on the doxycycline profile page.

Summary for NDA: 050805

Tradename:
ORACEA
Applicant:
Galderma Labs Lp
Ingredient:
doxycycline
Patents:12
Therapeutic Class:Antibacterials
Dermatological Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 050805

Ingredient-typeTetracyclines

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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength40MG
Approval Date:May 26, 2006TE:RLD:Yes
Patent:5,789,395Patent Expiration:Aug 30, 2016Product Flag?Substance Flag?Delist Request?Y
Patented Use:TREATMENT OF ONLY INFLAMMATORY LESIONS (PAPULES AND PUSTILES) OF ROSACEA
Patent:5,919,775Patent Expiration:Aug 30, 2016Product Flag?Substance Flag?Delist Request?Y
Patented Use:TREATMENT OF ONLY INFLAMMATORY LESIONS (PAPULES AND PUSTILES) OF ROSACEA
Patent:7,211,267Patent Expiration:Apr 5, 2022Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF ONLY INFLAMMATORY LESIONS (PAPULES AND PUSTILES) OF ROSACEA

Expired Orange Book Patents for NDA: 050805

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Galderma Labs Lp
ORACEA
doxycycline
CAPSULE;ORAL050805-001May 26, 20065,789,395► subscribe
Galderma Labs Lp
ORACEA
doxycycline
CAPSULE;ORAL050805-001May 26, 20065,919,775► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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