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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 011689
Company: PHARMOBEDIENT

Products on NDA 011689

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PHENERGAN	PROMETHAZINE HYDROCHLORIDE	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY;RECTAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 011689

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/27/1960	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/04/2015	SUPPL-25	Manufacturing (CMC)		Label is not available on this site.
11/08/2004	SUPPL-24	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/11689s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/11689s024ltr.pdf
09/12/2001	SUPPL-21	Manufacturing (CMC)-Control		Label is not available on this site.
12/26/2002	SUPPL-20	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/11689slr016,018,019,020ltr.pdf
12/26/2002	SUPPL-19	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/11689slr016,018,019,020ltr.pdf
12/26/2002	SUPPL-18	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/11689slr016,018,019,020ltr.pdf
08/01/2001	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
12/26/2002	SUPPL-16	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/11689slr016,018,019,020ltr.pdf
07/01/1994	SUPPL-15	Manufacturing (CMC)-Control		Label is not available on this site.
03/30/1992	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
04/28/1993	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
06/30/1988	SUPPL-10	Manufacturing (CMC)-Control		Label is not available on this site.
01/22/1988	SUPPL-9	Labeling		Label is not available on this site.
05/29/1986	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 011689

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/08/2004	SUPPL-24	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/11689s024lbl.pdf

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