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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090431
Company: RISING

Products on ANDA 090431

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET, DELAYED RELEASE;ORAL	Discontinued	None	No	No
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET, DELAYED RELEASE;ORAL	Discontinued	None	No	No
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET, DELAYED RELEASE;ORAL	Discontinued	None	No	No
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 80MG BASE	TABLET, DELAYED RELEASE;ORAL	Discontinued	None	No	No
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 200MG BASE	TABLET, DELAYED RELEASE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 090431

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/28/2010	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
05/23/2016	SUPPL-10	Manufacturing (CMC)-New Strength	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/90431Orig1s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/090431Orig1s010ltr.pdf
12/11/2015	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
09/16/2015	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
01/16/2015	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
04/29/2016	SUPPL-5	Manufacturing (CMC)-New Strength	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/090431Orig1s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/090431Orig1s005ltr.pdf
05/19/2016	SUPPL-4	Manufacturing (CMC)-New Strength	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/090431Orig1s004ltr.pdf
12/15/2011	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Labels for ANDA 090431

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/23/2016	SUPPL-10	Manufacturing (CMC)-New Strength	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/90431Orig1s010lbl.pdf
04/29/2016	SUPPL-5	Manufacturing (CMC)-New Strength	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/090431Orig1s005lbl.pdf

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