Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 062581
Company: TEVA

Products on ANDA 062581

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DOXY-LEMMON	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 062581

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/15/1985	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
05/19/2014	SUPPL-22	Labeling-Package Insert		Label is not available on this site.
08/30/2001	SUPPL-21	Manufacturing (CMC)-Facility		Label is not available on this site.
03/02/1995	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
01/26/1994	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
01/26/1994	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
01/26/1994	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
01/26/1994	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
01/26/1994	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
01/26/1994	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
08/31/1993	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
08/31/1993	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
04/01/1993	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
04/01/1993	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
10/21/1992	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
03/22/1989	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.