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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022007
Company: MYLAN SPECLT

Medication Guide

Other Important Information from FDA

Products on NDA 022007

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PERFOROMIST	FORMOTEROL FUMARATE	0.02MG/2ML	SOLUTION;INHALATION	Prescription	AN	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022007

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/11/2007	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022007s000TAltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022007s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022007_perforomist_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/29/2019	SUPPL-15	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022007s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022007Orig1s015ltr.pdf
10/17/2018	SUPPL-14	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022007s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022007Orig1s014ltr.pdf
11/30/2017	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022007s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022007Orig1s012ltr.pdf
03/19/2014	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
09/25/2012	SUPPL-8	REMS-Assessment	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022007Orig1s007,s008ltr.pdf
09/25/2012	SUPPL-7	REMS-Modified	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022007Orig1s007,s008ltr.pdf
01/11/2012	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022007s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022007s006ltr.pdf
02/01/2011	SUPPL-5	REMS-Proposal	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022007s005ltr.pdf
06/02/2010	SUPPL-4	Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022007s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022007s004ltr.pdf

Labels for NDA 022007

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/29/2019	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022007s015lbl.pdf
10/17/2018	SUPPL-14	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022007s014lbl.pdf
10/17/2018	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022007s014lbl.pdf
11/30/2017	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022007s012lbl.pdf
01/11/2012	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022007s006lbl.pdf
06/02/2010	SUPPL-4	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022007s004lbl.pdf
05/11/2007	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022007lbl.pdf

Therapeutic Equivalents for NDA 022007

PERFOROMIST

SOLUTION;INHALATION; 0.02MG/2ML
TE Code = AN

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FORMOTEROL FUMARATE	FORMOTEROL FUMARATE	0.02MG/2ML	SOLUTION;INHALATION	Prescription	No	AN	215078	ALEMBIC
FORMOTEROL FUMARATE	FORMOTEROL FUMARATE	0.02MG/2ML	SOLUTION;INHALATION	Prescription	No	AN	216486	AUCTA
FORMOTEROL FUMARATE	FORMOTEROL FUMARATE	0.02MG/2ML	SOLUTION;INHALATION	Prescription	No	AN	215053	LUPIN
FORMOTEROL FUMARATE	FORMOTEROL FUMARATE	0.02MG/2ML	SOLUTION;INHALATION	Prescription	No	AN	215883	MANKIND PHARMA
FORMOTEROL FUMARATE	FORMOTEROL FUMARATE	0.02MG/2ML	SOLUTION;INHALATION	Prescription	No	AN	215621	SLAYBACK PHARMA LLC
FORMOTEROL FUMARATE	FORMOTEROL FUMARATE	0.02MG/2ML	SOLUTION;INHALATION	Prescription	No	AN	091141	TEVA PHARMS USA INC
PERFOROMIST	FORMOTEROL FUMARATE	0.02MG/2ML	SOLUTION;INHALATION	Prescription	Yes	AN	022007	MYLAN SPECLT

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