Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216631
Company: LUPIN

Products on ANDA 216631

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 216631

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	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/216631Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/05/2025	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 216631

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	219978	AIPING PHARM INC
DOXYCYCLINE	DOXYCYCLINE	40MG	CAPSULE;ORAL	Prescription	No	AB	217674	ALEMBIC
DOXYCYCLINE	DOXYCYCLINE	40MG	CAPSULE;ORAL	Prescription	No	AB	217170	APOTEX
DOXYCYCLINE	DOXYCYCLINE	40MG	CAPSULE;ORAL	Prescription	No	AB	218034	DR REDDYS
DOXYCYCLINE	DOXYCYCLINE	40MG	CAPSULE;ORAL	Prescription	No	AB	216631	LUPIN
DOXYCYCLINE	DOXYCYCLINE	40MG	CAPSULE;ORAL	Prescription	No	AB	210381	MACLEODS PHARMS LTD
DOXYCYCLINE	DOXYCYCLINE	40MG	CAPSULE;ORAL	Prescription	No	AB	217098	PRINSTON INC
ORACEA	DOXYCYCLINE	40MG	CAPSULE;ORAL	Prescription	Yes	AB	050805	GALDERMA LABS LP