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): 065095
Company: HIKMA INTL PHARMS

Products on ANDA 065095

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065095

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/02/2003	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
08/07/2023	SUPPL-33	Labeling-Package Insert		Label is not available on this site.
08/07/2023	SUPPL-31	Labeling-Package Insert		Label is not available on this site.
08/07/2023	SUPPL-25	Labeling-Package Insert		Label is not available on this site.
08/07/2023	SUPPL-24	Labeling-Package Insert		Label is not available on this site.
08/07/2023	SUPPL-23	Labeling-Package Insert		Label is not available on this site.
08/07/2023	SUPPL-21	Labeling-Package Insert		Label is not available on this site.
08/07/2023	SUPPL-20	Labeling-Container/Carton Labels		Label is not available on this site.
08/07/2023	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
06/25/2014	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/065095Orig1s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/065095Orig1s014ltr.pdf
11/30/2011	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
05/12/2009	SUPPL-10	Labeling		Label is not available on this site.

Labels for ANDA 065095

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/25/2014	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/065095Orig1s014lbl.pdf

Therapeutic Equivalents for ANDA 065095

DOXYCYCLINE HYCLATE

TABLET;ORAL; EQ 100MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	210664	ACELLA
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	062421	ACTAVIS LABS FL INC
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	207773	CADILA
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	062269	CARIBE HOLDINGS
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	211343	CHANGZHOU PHARM
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	062505	CHARTWELL
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	065095	HIKMA INTL PHARMS
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	207558	NOVEL LABS INC
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	062677	SUN PHARM INDUSTRIES

Top