Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 062337
Company: STRIDES PHARMA

Products on ANDA 062337

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 062337

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/29/1982	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
06/30/2015	SUPPL-25	Labeling-Package Insert		Label is not available on this site.
09/02/2014	SUPPL-24	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
12/23/2002	SUPPL-23	Labeling		Label is not available on this site.
02/05/1998	SUPPL-22	Manufacturing (CMC)		Label is not available on this site.
02/25/1998	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
10/22/1993	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
10/22/1993	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
06/01/1993	SUPPL-17	Labeling		Label is not available on this site.
12/16/1992	SUPPL-16	Labeling		Label is not available on this site.
05/12/1992	SUPPL-15	Labeling		Label is not available on this site.
05/12/1992	SUPPL-14	Labeling		Label is not available on this site.
01/31/1990	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
01/31/1990	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
04/25/1989	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.