Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 219978
Company: AIPING PHARM INC

Products on ANDA 219978

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 219978

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/01/2025	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 219978

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