Viewing data from:

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