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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091406
Company: MYLAN LABS LTD

Products on ANDA 091406

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091406

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/21/2012	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
06/18/2020	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
06/18/2020	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
06/18/2020	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
06/16/2014	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 091406

DOXYCYCLINE

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

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