Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 085417
Company: CHARTWELL RX

Products on ANDA 085417

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PHENTERMINE HYDROCHLORIDE	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 085417

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/10/1980	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/06/2000	SUPPL-26	Manufacturing (CMC)-Facility		Label is not available on this site.
11/03/1998	SUPPL-24	Labeling		Label is not available on this site.
08/19/1998	SUPPL-23	Labeling		Label is not available on this site.
04/08/1998	SUPPL-22	Labeling		Label is not available on this site.
12/19/1997	SUPPL-21	Labeling		Label is not available on this site.
10/16/1992	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
09/19/1989	SUPPL-18	Labeling		Label is not available on this site.
05/31/1989	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
06/27/1988	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
06/27/1988	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
04/25/1984	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
12/21/1983	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
12/21/1983	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
06/14/1983	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.