Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 040372
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 25MG/ML INJECTABLE;INJECTION Discontinued None No No
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 50MG/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
06/08/2000 ORIG-1 Approval Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/40372_Promethazine%20Hydrochloride_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/40372ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/040372_promethazine_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/20/2009 SUPPL-16 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

02/25/2008 SUPPL-14 Labeling

Label is not available on this site.

10/25/2007 SUPPL-13 Labeling

Label is not available on this site.

06/07/2006 SUPPL-11 Labeling

Label is not available on this site.

03/13/2006 SUPPL-10 Labeling

Label is not available on this site.

04/19/2004 SUPPL-4 Labeling

Label is not available on this site.

03/27/2002 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

02/14/2001 SUPPL-1 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/08/2000 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/40372_Promethazine%20Hydrochloride_Prntlbl.pdf

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