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NARATRIPTAN

ANDA

NARATRIPTAN HYDROCHLORIDE | A078751 | ANI PHARMACEUTICALS INC

2 strengths0 unique patents0 unique exclusivities

Citizen Petitions

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Alexander Mauskop FDA-2026-P-0925 · 39 docket documents Alexander Mauskop filed this citizen petition in January 2026 requesting that the FDA amend the prescription status of seven triptan medications—sumatriptan, naratriptan, rizatriptan, eletriptan, zolmitriptan, almotriptan, and frovatriptan—to allow their availability as over-the-counter products by	Other	2026-01-30	Open	Alexander Mauskop

Source: Regulations.gov. FDA citizen petitions matched by application number.

API Supply Chain4 active DMFs2 inactive

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

DR REDDYS LABORATORIES LTDNARATRIPTAN HYDROCHLORIDE

DMF 176482004

ORBION PHARMACEUTICALS PRIVATE LTDNARATRIPTAN HYDROCHLORIDE (NON-STERILE BULK API)

DMF 221312008

SUN PHARMACEUTICAL INDUSTRIES LTDNARATRIPTAN HYDROCHLORIDE USP

DMF 227292009

USV PRIVATE LTDNARATRIPTAN HYDROCHLORIDE USP

DMF 229532009

IND SWIFT LABORATORIES LTDInactiveNARATRIPTAN HYDROCHLORIDE USP

DMF 224222008

APOTEX PHARMACHEM INDIA PVT LTDInactiveNARATRIPTAN HYDROCHLORIDE USP

DMF 226212009

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jul 9, 2010	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

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#001 — EQ 1MG BASE

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jul 7, 2010

No patent or exclusivity listings for this strength.

#002 — EQ 2.5MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jul 7, 2010