An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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
04/09/2026	SUPPL-24	Labeling-Package Insert		Label is not available on this site.
04/09/2026	SUPPL-20	Labeling-Package Insert		Label is not available on this site.
04/09/2026	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
04/09/2026	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
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

Top