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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 214378
Company: HUMANWELL

Products on ANDA 214378

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TAPENTADOL HYDROCHLORIDE	TAPENTADOL HYDROCHLORIDE	EQ 50MG BASE	TABLET;ORAL	Prescription	AB	No	No
TAPENTADOL HYDROCHLORIDE	TAPENTADOL HYDROCHLORIDE	EQ 75MG BASE	TABLET;ORAL	Prescription	AB	No	No
TAPENTADOL HYDROCHLORIDE	TAPENTADOL HYDROCHLORIDE	EQ 100MG BASE	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 214378

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/27/2026	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/214378Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 214378

TAPENTADOL HYDROCHLORIDE

TABLET;ORAL; EQ 50MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NUCYNTA	TAPENTADOL HYDROCHLORIDE	EQ 50MG BASE	TABLET;ORAL	Prescription	Yes	AB	022304	COLLEGIUM PHARM INC
TAPENTADOL HYDROCHLORIDE	TAPENTADOL HYDROCHLORIDE	EQ 50MG BASE	TABLET;ORAL	Prescription	No	AB	205057	HIKMA
TAPENTADOL HYDROCHLORIDE	TAPENTADOL HYDROCHLORIDE	EQ 50MG BASE	TABLET;ORAL	Prescription	No	AB	214378	HUMANWELL

TABLET;ORAL; EQ 75MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NUCYNTA	TAPENTADOL HYDROCHLORIDE	EQ 75MG BASE	TABLET;ORAL	Prescription	Yes	AB	022304	COLLEGIUM PHARM INC
TAPENTADOL HYDROCHLORIDE	TAPENTADOL HYDROCHLORIDE	EQ 75MG BASE	TABLET;ORAL	Prescription	No	AB	205057	HIKMA
TAPENTADOL HYDROCHLORIDE	TAPENTADOL HYDROCHLORIDE	EQ 75MG BASE	TABLET;ORAL	Prescription	No	AB	214378	HUMANWELL

TABLET;ORAL; EQ 100MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NUCYNTA	TAPENTADOL HYDROCHLORIDE	EQ 100MG BASE	TABLET;ORAL	Prescription	Yes	AB	022304	COLLEGIUM PHARM INC
TAPENTADOL HYDROCHLORIDE	TAPENTADOL HYDROCHLORIDE	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	205057	HIKMA
TAPENTADOL HYDROCHLORIDE	TAPENTADOL HYDROCHLORIDE	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	214378	HUMANWELL

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