Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 070298
Company: WEST-WARD PHARMS INT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NALOXONE NALOXONE HYDROCHLORIDE 0.4MG/ML 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
10/22/1985 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/04/1999 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

01/11/1999 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

01/11/1999 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

08/26/1996 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

03/26/1993 SUPPL-9 Labeling

Label is not available on this site.

01/16/1991 SUPPL-7 Labeling

Label is not available on this site.

01/16/1991 SUPPL-6 Labeling

Label is not available on this site.

12/19/1986 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

01/29/1987 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

01/29/1987 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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