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Drugs@FDA: FDA-Approved Drugs

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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	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	062432	MYLAN
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	209560	NOSTRUM LABS INC
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
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	207773	ZYDUS LIFESCIENCES

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