Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 062475
Company: FRESENIUS KABI USA

Products on ANDA 062475

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DOXY 100	DOXYCYCLINE HYCLATE	EQ 100MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	Yes
DOXY 200	DOXYCYCLINE HYCLATE	EQ 200MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 062475

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/09/1983	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
04/22/2020	SUPPL-50	Labeling-Package Insert		Label is not available on this site.
04/22/2020	SUPPL-49	Labeling-Package Insert		Label is not available on this site.
01/26/2016	SUPPL-46	Labeling-Package Insert		Label is not available on this site.
01/26/2016	SUPPL-45	Labeling-Package Insert		Label is not available on this site.
01/26/2016	SUPPL-40	Labeling-Package Insert		Label is not available on this site.
01/28/2014	SUPPL-38	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/062475s038lbl.pdf
02/27/2008	SUPPL-32	Labeling		Label is not available on this site.
10/17/2005	SUPPL-22	Labeling		Label is not available on this site.
04/02/2003	SUPPL-19	Labeling		Label is not available on this site.
12/05/2002	SUPPL-17	Manufacturing (CMC)-Facility		Label is not available on this site.
04/02/2003	SUPPL-16	Labeling		Label is not available on this site.
05/08/1996	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
09/03/1992	SUPPL-11	Labeling		Label is not available on this site.
11/08/1994	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
11/03/1988	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.

Labels for ANDA 062475

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/28/2014	SUPPL-38	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/062475s038lbl.pdf

Therapeutic Equivalents for ANDA 062475

DOXY 100

INJECTABLE;INJECTION; EQ 100MG BASE/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DOXY 100	DOXYCYCLINE HYCLATE	EQ 100MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	062475	FRESENIUS KABI USA
DOXYCYCLINE	DOXYCYCLINE HYCLATE	EQ 100MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	091406	MYLAN LABS LTD
DOXYCYCLINE	DOXYCYCLINE HYCLATE	EQ 100MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	207757	ZYDUS PHARMS
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 100MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	215583	GLAND PHARMA LTD
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 100MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	217794	LUPIN LTD
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 100MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	062992	WEST-WARD PHARMS INT

DOXY 200

INJECTABLE;INJECTION; EQ 200MG BASE/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DOXY 200	DOXYCYCLINE HYCLATE	EQ 200MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	062475	FRESENIUS KABI USA
DOXYCYCLINE	DOXYCYCLINE HYCLATE	EQ 200MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	207757	ZYDUS PHARMS
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 200MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	062992	WEST-WARD PHARMS INT