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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210662
Company: BRECKENRIDGE

Products on ANDA 210662

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TETRACYCLINE HYDROCHLORIDE	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE;ORAL	Prescription	AB	No	No
TETRACYCLINE HYDROCHLORIDE	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 210662

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/07/2018	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 210662

TETRACYCLINE HYDROCHLORIDE

CAPSULE;ORAL; 250MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ACHROMYCIN V	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE;ORAL	Prescription	Yes	AB	050278	AVET
TETRACYCLINE HYDROCHLORIDE	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE;ORAL	Prescription	No	AB	210674	AMNEAL PHARMS NY
TETRACYCLINE HYDROCHLORIDE	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE;ORAL	Prescription	No	AB	210662	BRECKENRIDGE
TETRACYCLINE HYDROCHLORIDE	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE;ORAL	Prescription	No	AB	062752	CHARTWELL TETRA
TETRACYCLINE HYDROCHLORIDE	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE;ORAL	Prescription	No	AB	212635	NOVITIUM PHARMA
TETRACYCLINE HYDROCHLORIDE	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE;ORAL	Prescription	No	AB	061837	WATSON LABS

CAPSULE;ORAL; 500MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ACHROMYCIN V	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE;ORAL	Prescription	Yes	AB	050278	AVET
TETRACYCLINE HYDROCHLORIDE	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE;ORAL	Prescription	No	AB	210674	AMNEAL PHARMS NY
TETRACYCLINE HYDROCHLORIDE	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE;ORAL	Prescription	No	AB	210662	BRECKENRIDGE
TETRACYCLINE HYDROCHLORIDE	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE;ORAL	Prescription	No	AB	062752	CHARTWELL TETRA
TETRACYCLINE HYDROCHLORIDE	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE;ORAL	Prescription	No	AB	212635	NOVITIUM PHARMA
TETRACYCLINE HYDROCHLORIDE	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE;ORAL	Prescription	No	AB	061837	WATSON LABS

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