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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040372
Company: HOSPIRA

Products on ANDA 040372

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040372

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.

Labels for ANDA 040372

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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