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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050805
Company: GALDERMA LABS LP

Products on NDA 050805

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ORACEA	DOXYCYCLINE	40MG	CAPSULE;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050805

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/26/2006	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050805lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050805s000LTR.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/050805s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/15/2021	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050805s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/050805Orig1s011ltr.pdf
09/03/2015	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
06/24/2015	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
07/25/2013	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050805s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050805Orig1s008ltr.pdf
11/07/2012	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050805s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050805Orig1s007ltr.pdf
05/13/2010	SUPPL-2	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050805s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050805s002ltr.pdf

Labels for NDA 050805

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/15/2021	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050805s011lbl.pdf
07/25/2013	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050805s008lbl.pdf
11/07/2012	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050805s007lbl.pdf
05/13/2010	SUPPL-2	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050805s002lbl.pdf
05/26/2006	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050805lbl.pdf

Therapeutic Equivalents for NDA 050805

ORACEA

CAPSULE;ORAL; 40MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DOXYCYCLINE	DOXYCYCLINE	40MG	CAPSULE;ORAL	Prescription	No	AB	218034	DR REDDYS
DOXYCYCLINE	DOXYCYCLINE	40MG	CAPSULE;ORAL	Prescription	No	AB	216631	LUPIN
ORACEA	DOXYCYCLINE	40MG	CAPSULE;ORAL	Prescription	Yes	AB	050805	GALDERMA LABS LP

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