Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 003977
Company: PARKEDALE

Products on NDA 003977

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
THEELIN	ESTRONE	1MG/ML	INJECTABLE;INJECTION	Discontinued	None	No	No
THEELIN	ESTRONE	2MG/ML	INJECTABLE;INJECTION	Discontinued	None	No	No
THEELIN	ESTRONE	5MG/ML	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 003977

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/12/1941	ORIG-1	Approval		UNKNOWN		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/19/1988	SUPPL-13	Labeling		Label is not available on this site.
05/17/1988	SUPPL-12	Labeling		Label is not available on this site.
12/29/1987	SUPPL-10	Labeling		Label is not available on this site.
04/07/1987	SUPPL-8	Labeling		Label is not available on this site.
09/29/1986	SUPPL-7	Labeling		Label is not available on this site.
03/27/1996	SUPPL-6	Labeling		Label is not available on this site.
10/20/1978	SUPPL-4	Labeling		Label is not available on this site.
03/27/1996	SUPPL-3	Labeling		Label is not available on this site.
03/27/1996	SUPPL-2	Labeling		Label is not available on this site.