Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 062418
Company: MUTUAL PHARM

Products on ANDA 062418

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 062418

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/28/1983	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
12/01/1998	SUPPL-28	Manufacturing (CMC)		Label is not available on this site.
08/16/1995	SUPPL-27	Manufacturing (CMC)		Label is not available on this site.
12/23/1994	SUPPL-26	Manufacturing (CMC)		Label is not available on this site.
10/11/1994	SUPPL-25	Manufacturing (CMC)		Label is not available on this site.
12/13/1993	SUPPL-24	Labeling		Label is not available on this site.
07/22/1993	SUPPL-23	Labeling		Label is not available on this site.
05/01/1992	SUPPL-22	Labeling		Label is not available on this site.
04/03/1992	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
04/03/1992	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
04/03/1992	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
04/03/1992	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
02/11/1992	SUPPL-15	Labeling		Label is not available on this site.
01/10/1995	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.