Sciegen Valsartan/Hydrochlorothiazide Tablets Approved April 23

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Sciegen Valsartan/Hydrochlorothiazide Tablets Approved April 23

FDA Drugs@FDA - New Applications and Actions

Published April 23rd, 2026

Detected April 27th, 2026

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Summary

FDA approved ANDA 204687 for Valsartan and Hydrochlorothiazide combination tablets in five strengths (12.5mg/80mg, 12.5mg/160mg, 12.5mg/320mg, 25mg/160mg, 25mg/320mg) submitted by SCIEGEN PHARMS on April 23, 2026. The product carries TE Code AB (therapeutically equivalent to the reference listed drug Diovan HCT) and is classified as a prescription medication. This approval marks Sciegen Pharms as the ninth approved generic manufacturer for this combination product, enabling pharmacy-level substitution in the US market.

Published by FDA on accessdata.fda.gov . Detected, standardized, and enriched by GovPing. Review our methodology and editorial standards .

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What changed

FDA granted approval to Abbreviated New Drug Application (ANDA) 204687 submitted by SCIEGEN PHARMS for Valsartan and Hydrochlorothiazide tablets across five strength combinations, all designated as TE Code AB (therapeutically equivalent). The product received Prescription marketing status and is not listed as a Reference Listed Drug (RLD) or Reference Standard (RS).

Affected parties—wholesalers, pharmacy benefit managers, and health systems evaluating generic substitution options—may now consider Sciegen Pharms as an additional approved supplier for this antihypertensive combination. Pharmacies in states permitting therapeutic substitution may substitute Sciegen's approved product for Diovan HCT (Novartis, ANDA 020818) when TE Code AB is satisfied. No new compliance obligations are created beyond standard CGMP and labeling requirements already applicable to ANDA holders.

Archived snapshot

Apr 27, 2026

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Abbreviated New Drug Application (ANDA): 204687
Company: SCIEGEN PHARMS
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Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VALSARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; VALSARTAN	12.5MG;80MG	TABLET;ORAL	Prescription	AB	No	No
VALSARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; VALSARTAN	12.5MG;160MG	TABLET;ORAL	Prescription	AB	No	No
VALSARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; VALSARTAN	12.5MG;320MG	TABLET;ORAL	Prescription	AB	No	No
VALSARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; VALSARTAN	25MG;160MG	TABLET;ORAL	Prescription	AB	No	No
VALSARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; VALSARTAN	25MG;320MG	TABLET;ORAL	Prescription	AB	No	No

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/23/2026	ORIG-1	Approval	Label is not available on this site.

VALSARTAN AND HYDROCHLOROTHIAZIDE

TABLET;ORAL; 12.5MG;80MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DIOVAN HCT	HYDROCHLOROTHIAZIDE; VALSARTAN	12.5MG;80MG	TABLET;ORAL	Prescription	Yes	AB	020818	NOVARTIS
VALSARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; VALSARTAN	12.5MG;80MG	TABLET;ORAL	Prescription	No	AB	201662	ALEMBIC
VALSARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; VALSARTAN	12.5MG;80MG	TABLET;ORAL	Prescription	No	AB	204382	AMNEAL PHARMS
VALSARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; VALSARTAN	12.5MG;80MG	TABLET;ORAL	Prescription	No	AB	202519	AUROBINDO PHARMA LTD
VALSARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; VALSARTAN	12.5MG;80MG	TABLET;ORAL	Prescription	No	AB	078946	LUPIN LTD
VALSARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; VALSARTAN	12.5MG;80MG	TABLET;ORAL	Prescription	No	AB	203145	MACLEODS PHARMS LTD
VALSARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; VALSARTAN	12.5MG;80MG	TABLET;ORAL	Prescription	No	AB	078020	MYLAN PHARMS INC
VALSARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; VALSARTAN	12.5MG;80MG	TABLET;ORAL	Prescription	No	AB	206083	PRINSTON INC
VALSARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; VALSARTAN	12.5MG;80MG	TABLET;ORAL	Prescription	No	AB	204687	SCIEGEN PHARMS

TABLET;ORAL; 12.5MG;160MG
TE Code = AB

Mentioned entities

Food and Drug Administration

Parties

SCIEGEN PHARMS

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FDA Drugs@FDA - New Applications and Actions accessdata.fda.gov/scripts/cder/daf/index.cfm?event=reportsSearch.process

Healthcare & Life Sciences

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Last updated

April 27, 2026

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Classification

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FDA

Published

April 23rd, 2026

Instrument

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Executive

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Final

Change scope

Minor

Who this affects

Applies to

Drug manufacturers Pharmaceutical companies

Industry sector

3254 Pharmaceutical Manufacturing

Activity scope

Generic drug approval Pharmaceutical market entry Generic substitution

Geographic scope

United States US

Taxonomy

Primary area

Pharmaceuticals

Operational domain

Regulatory Affairs

Topics

Healthcare Intellectual Property

Sciegen Valsartan/Hydrochlorothiazide Tablets Approved April 23

Summary

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Original Approvals or Tentative Approvals

VALSARTAN AND HYDROCHLOROTHIAZIDE

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