Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 007942
Company: FOREST LABS

Products on NDA 007942

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SUS-PHRINE SULFITE FREE	EPINEPHRINE	5MG/ML	INJECTABLE;INJECTION	Discontinued	None	No	No
SUS-PHRINE SULFITE FREE	EPINEPHRINE	1.5MG/AMP	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 007942

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/08/1951	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/07/1998	SUPPL-17	Manufacturing (CMC)-Control		Label is not available on this site.
02/05/1999	SUPPL-16	Labeling		Label is not available on this site.
02/08/1995	SUPPL-15	Manufacturing (CMC)-Control		Label is not available on this site.
12/20/1993	SUPPL-14	Labeling		Label is not available on this site.
12/07/2007	SUPPL-12	Labeling		Label is not available on this site.
01/19/1990	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
12/07/2007	SUPPL-9	Labeling		Label is not available on this site.
10/16/1985	SUPPL-8	Manufacturing (CMC)-Control		Label is not available on this site.
12/06/1984	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.
11/19/1986	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
10/26/1983	SUPPL-5	Labeling		Label is not available on this site.
10/26/1983	SUPPL-3	Labeling		Label is not available on this site.
10/26/1983	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
12/07/2007	SUPPL-1	Efficacy		Label is not available on this site.