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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 010926
Company: MYLAN

Products on NDA 010926

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PHENERGAN	PROMETHAZINE HYDROCHLORIDE	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY;RECTAL	Discontinued	None	Yes	No
PHENERGAN	PROMETHAZINE HYDROCHLORIDE	12.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY;RECTAL	Discontinued	None	Yes	No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 010926

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/05/1958	ORIG-1	Approval	Type 3 - New Dosage Form	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-31	Manufacturing (CMC)		Label is not available on this site.
11/08/2004	SUPPL-30	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/10926s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/10926s030ltr.pdf
09/12/2001	SUPPL-27	Manufacturing (CMC)-Control		Label is not available on this site.
12/26/2002	SUPPL-22	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/10926slr017,020,021,022ltr.pdf
12/26/2002	SUPPL-21	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/10926slr017,020,021,022ltr.pdf
12/26/2002	SUPPL-20	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/10926slr017,020,021,022ltr.pdf
07/27/2001	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
06/22/2001	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
12/26/2002	SUPPL-17	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/10926slr017,020,021,022ltr.pdf
07/01/1994	SUPPL-16	Manufacturing (CMC)-Control		Label is not available on this site.
03/30/1992	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
04/28/1993	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
06/30/1988	SUPPL-11	Manufacturing (CMC)-Control		Label is not available on this site.
01/22/1988	SUPPL-10	Labeling		Label is not available on this site.
05/29/1986	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 010926

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/08/2004	SUPPL-30	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/10926s030lbl.pdf

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