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-three 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

Pharmacology for NDA: 050805

Medical Subject Heading (MeSH) Categories for 050805

Anti-Bacterial Agents
Antimalarials

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:	RX	Dosage:	CAPSULE;ORAL			Strength	40MG
Approval Date:	May 26, 2006	TE:	AB	RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Dec 19, 2027	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF ONLY INFLAMMATORY LESIONS (PAPULES AND PUSTULES) OF ROSACEA
Patent:	⤷ Sign Up	Patent Expiration:	Dec 24, 2025	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF ONLY INFLAMMATORY LESIONS (PAPULES AND PUSTULES) OF ROSACEA
Patent:	⤷ Sign Up	Patent Expiration:	Apr 7, 2024	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF ONLY INFLAMMATORY LESIONS (PAPULES AND PUSTULES) OF ROSACEA

Expired US Patents for NDA 050805

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

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