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TAPENTADOL HYDROCHLORIDE

ANDA

TAPENTADOL HYDROCHLORIDE | A214378 | EPIC PHARMA LLC

3 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: NUCYNTA(TE code: AB)

API Supply Chain5 active DMFs

4 active API suppliers hold Drug Master Files for this ingredient.

NORAMCO LLCTAPENTADOL HYDROCHLORIDE (R331333) DRUG SUBSTANCE

DMF 210842008

CURIA MISSOURI INCTAPENTADOL HYDROCHLORIDE DRUG SUBSTANCE

DMF 264902012

ALKEM LABORATORIES LTDTAPENTADOL HYDROCHLORIDE

DMF 265192012

ALKEM LABORATORIES LTDTAPENTADOL HYDROCHLORIDE

DMF 314352017

MSN ORGANICS PRIVATE LTDTAPENTADOL HYDROCHLORIDE

DMF 413162025

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Feb 11, 2026	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — EQ 50MG BASE

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jan 27, 2026

No patent or exclusivity listings for this strength.

#002 — EQ 75MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jan 27, 2026

#003 — EQ 100MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jan 27, 2026

Change History (6)

Recent changes detected for this application.

MODIFIEDApplicant Full Name7/1/2026

EPIC PHARMA LLC became the applicant for tapentadol hydrochloride NDA 214378 supplement 002, replacing HUMANWELL PHARMACEUTICAL US INC.

Old: HUMANWELL PHARMACEUTICAL US INC

New: EPIC PHARMA LLC

MODIFIEDApplicant7/1/2026

EPIC PHARMA LLC became the applicant for tapentadol hydrochloride NDA 214378 following a transfer from HUMANWELL.

Old: HUMANWELL

New: EPIC PHARMA LLC

MODIFIEDApplicant Full Name7/1/2026

Applicant for tapentadol hydrochloride (NDA 214378) changed from Humanwell Pharmaceutical US Inc to Epic Pharma LLC.

Old: HUMANWELL PHARMACEUTICAL US INC

New: EPIC PHARMA LLC

MODIFIEDApplicant Full Name7/1/2026

Epic Pharma LLC replaced Humanwell Pharmaceutical US Inc as the applicant for tapentadol hydrochloride NDA 214378.

Old: HUMANWELL PHARMACEUTICAL US INC

New: EPIC PHARMA LLC

MODIFIEDApplicant7/1/2026

Epic Pharma LLC replaced Humanwell as the NDA 214378 applicant for Tapentadol Hydrochloride oral solution, reflecting a change in product ownership or sponsorship.

Old: HUMANWELL

New: EPIC PHARMA LLC

MODIFIEDApplicant7/1/2026

EPIC Pharma LLC became the applicant for NDA 214378 (Tapentadol Hydrochloride) following a change from Humanwell.

Old: HUMANWELL

New: EPIC PHARMA LLC