Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 087907
Company: ARMSTRONG PHARMS

Products on ANDA 087907

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
EPINEPHRINE	EPINEPHRINE	0.2MG/INH	AEROSOL, METERED;INHALATION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 087907

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/23/1984	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/25/2010	SUPPL-38	Labeling-Container/Carton Labels		Label is not available on this site.
06/12/2009	SUPPL-34	Labeling		Label is not available on this site.
05/09/2008	SUPPL-24	Labeling		Label is not available on this site.
07/09/2002	SUPPL-20	Labeling		Label is not available on this site.
12/04/2001	SUPPL-19	Manufacturing (CMC)-Packaging		Label is not available on this site.
05/04/1995	SUPPL-18	Labeling		Label is not available on this site.
07/28/1993	SUPPL-17	Labeling		Label is not available on this site.
09/28/1990	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
02/26/1993	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
02/26/1993	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
02/26/1993	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
02/26/1993	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
10/25/1990	SUPPL-11	Labeling		Label is not available on this site.
02/15/1991	SUPPL-10	Labeling		Label is not available on this site.
05/16/1990	SUPPL-7	Labeling		Label is not available on this site.
05/16/1990	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
10/02/1989	SUPPL-2	Labeling		Label is not available on this site.