Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018123
Company: WEST-WARD PHARMS INT
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
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.

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