Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 070189
Company: WYETH AYERST
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NALOXONE NALOXONE HYDROCHLORIDE 0.02MG/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
10/02/1985 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/070189.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/05/1987 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

02/20/1987 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

01/22/1988 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

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