Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 063067
Company: ALVOGEN

Products on ANDA 063067

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DYNACIN	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE;ORAL	Discontinued	None	No	No
DYNACIN	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE;ORAL	Discontinued	None	No	No
DYNACIN	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 063067

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/31/1990	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
03/24/2026	SUPPL-49	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
03/24/2026	SUPPL-48	Labeling-Package Insert		Label is not available on this site.
03/24/2026	SUPPL-43	Labeling-Package Insert		Label is not available on this site.
12/23/2014	SUPPL-38	Labeling-Package Insert		Label is not available on this site.
08/04/2003	SUPPL-24	Labeling		Label is not available on this site.
09/15/1999	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
09/15/1999	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
09/15/1999	SUPPL-15	Labeling		Label is not available on this site.
09/15/1999	SUPPL-14	Manufacturing (CMC)-New Strength		Label is not available on this site.
12/02/1999	SUPPL-13	Labeling		Label is not available on this site.
12/02/1999	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
06/24/1999	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
04/14/1997	SUPPL-10	Labeling		Label is not available on this site.
04/24/1996	SUPPL-9	Labeling		Label is not available on this site.
06/24/1996	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
06/24/1996	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
06/24/1996	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
11/07/1994	SUPPL-5	Labeling		Label is not available on this site.
12/21/1993	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
01/13/1993	SUPPL-3	Labeling		Label is not available on this site.
03/16/1992	SUPPL-2	Labeling		Label is not available on this site.
09/30/1991	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.