Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018123
Company: HIKMA

Products on NDA 018123

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FACTREL	GONADORELIN HYDROCHLORIDE	EQ 0.1MG BASE/VIAL	INJECTABLE;INJECTION	Discontinued	None	No	No
FACTREL	GONADORELIN HYDROCHLORIDE	EQ 0.2MG BASE/VIAL	INJECTABLE;INJECTION	Discontinued	None	No	No
FACTREL	GONADORELIN HYDROCHLORIDE	EQ 0.5MG BASE/VIAL	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018123

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/30/1982	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/19/2002	SUPPL-14	Manufacturing (CMC)-Control	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18123scs014ltr.pdf
06/02/2000	SUPPL-12	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
05/09/1994	SUPPL-11	Labeling		Label is not available on this site.
02/22/1994	SUPPL-10	Labeling		Label is not available on this site.
07/30/1990	SUPPL-9	Labeling		Label is not available on this site.
11/08/1989	SUPPL-8	Labeling		Label is not available on this site.
08/08/1989	SUPPL-7	Labeling		Label is not available on this site.
11/21/1989	SUPPL-6	Manufacturing (CMC)-Packaging		Label is not available on this site.
07/27/1989	SUPPL-5	Manufacturing (CMC)-Control		Label is not available on this site.
02/24/1988	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
05/29/1987	SUPPL-2	Labeling		Label is not available on this site.
05/19/1983	SUPPL-1	Labeling		Label is not available on this site.