Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 087805
Company: CHARTWELL RX

Products on ANDA 087805

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 087805

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/06/1982	ORIG-1	Approval			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/87805ap.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/06/2000	SUPPL-22	Manufacturing (CMC)-Facility		Label is not available on this site.
10/19/1999	SUPPL-20	Labeling		Label is not available on this site.
11/03/1998	SUPPL-19	Labeling		Label is not available on this site.
08/19/1998	SUPPL-18	Labeling		Label is not available on this site.
04/08/1998	SUPPL-17	Labeling		Label is not available on this site.
12/19/1997	SUPPL-16	Labeling		Label is not available on this site.
06/30/1992	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
06/04/1990	SUPPL-12	Labeling		Label is not available on this site.
05/02/1989	SUPPL-11	Labeling		Label is not available on this site.
05/31/1989	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
06/27/1988	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
06/27/1988	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
12/22/1983	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
12/22/1983	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
02/10/1983	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.