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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 218034
Company: DR REDDYS

Products on ANDA 218034

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DOXYCYCLINE	DOXYCYCLINE	40MG	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 218034

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/08/2024	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 218034

DOXYCYCLINE

CAPSULE;ORAL; 40MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DOXYCYCLINE	DOXYCYCLINE	40MG	CAPSULE;ORAL	Prescription	No	AB	218034	DR REDDYS
DOXYCYCLINE	DOXYCYCLINE	40MG	CAPSULE;ORAL	Prescription	No	AB	216631	LUPIN
ORACEA	DOXYCYCLINE	40MG	CAPSULE;ORAL	Prescription	Yes	AB	050805	GALDERMA LABS LP

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