Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 060429
Company: APOTHECON

Products on ANDA 060429

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SUMYCIN	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE;ORAL	Discontinued	None	No	No
SUMYCIN	TETRACYCLINE HYDROCHLORIDE	100MG	CAPSULE;ORAL	Discontinued	None	No	No
SUMYCIN	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE;ORAL	Discontinued	None	No	No
SUMYCIN	TETRACYCLINE HYDROCHLORIDE	125MG	CAPSULE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 060429

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/17/1954	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
07/03/1996	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
11/01/1995	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
05/25/1994	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
10/06/1992	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
09/11/1992	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
05/23/1991	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
05/23/1991	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
03/17/1989	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
07/16/1997	SUPPL-9	Labeling		Label is not available on this site.
09/15/1989	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
04/01/1987	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.