Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040276
Company: ACTAVIS ELIZABETH

Products on ANDA 040276

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PHENTERMINE HYDROCHLORIDE	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040276

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/25/1998	ORIG-1	Approval			Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40276_Phentermine%20Hydrochloride_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/40276ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/040276_phentermine_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/31/2017	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
11/04/2015	SUPPL-15	Labeling-Package Insert, Labeling-Package Insert		Label is not available on this site.
11/02/2001	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
04/04/2001	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for ANDA 040276

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/25/1998	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40276_Phentermine%20Hydrochloride_Prntlbl.pdf