Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 214934
Company: NEXUS

Products on ANDA 214934

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 214934

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/12/2025	ORIG-1	Tentative Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 214934

MINOCYCLINE HYDROCHLORIDE

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
MINOCIN	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	Yes	AP	050444	REMPEX
MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	214934	NEXUS