Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 010831
Company: ORGANICS LAGRANGE

Products on NDA 010831

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CORTICOTROPIN	CORTICOTROPIN	40 UNITS/ML	INJECTABLE;INJECTION	Discontinued	None	No	No
CORTICOTROPIN	CORTICOTROPIN	80 UNITS/ML	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 010831

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/12/1957	ORIG-1	Approval	Type 3 - New Dosage Form	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
07/14/1992	SUPPL-54	Manufacturing (CMC)-Control		Label is not available on this site.
08/30/1989	SUPPL-53	Manufacturing (CMC)		Label is not available on this site.
04/28/1988	SUPPL-52	Labeling		Label is not available on this site.
01/09/1985	SUPPL-51	Labeling		Label is not available on this site.
12/01/1980	SUPPL-49	Efficacy		Label is not available on this site.
12/01/1980	SUPPL-48	Efficacy		Label is not available on this site.
08/17/1977	SUPPL-43	Labeling		Label is not available on this site.
08/17/1977	SUPPL-42	Labeling		Label is not available on this site.
02/17/1978	SUPPL-40	Manufacturing (CMC)-Control		Label is not available on this site.
02/09/1977	SUPPL-39	Labeling		Label is not available on this site.
08/05/1976	SUPPL-38	Manufacturing (CMC)		Label is not available on this site.
06/29/1976	SUPPL-37	Labeling		Label is not available on this site.
06/29/1976	SUPPL-36	Labeling		Label is not available on this site.
05/03/1976	SUPPL-35	Labeling		Label is not available on this site.
12/31/1975	SUPPL-34	Labeling		Label is not available on this site.
12/31/1975	SUPPL-32	Labeling		Label is not available on this site.