Changeflow GovPing Healthcare & Life Sciences Pantoprazole Sodium ANDA 219973 Approved, Shuan...
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Pantoprazole Sodium ANDA 219973 Approved, Shuangcheng, Apr 22

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Summary

FDA approved Abbreviated New Drug Application (ANDA) 219973 for Pantoprazole Sodium (EQ 40MG BASE/VIAL, Injectable;Intravenous) submitted by SHUANGCHENG. The approval was granted on April 22, 2026 as ORIG-1 (original application) under STANDARD submission classification with no orphan status. The drug holds TE Code AP (therapeutically equivalent to listed drug) and carries Prescription marketing status.

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What changed

FDA granted approval to ANDA 219973 for Pantoprazole Sodium injectable (EQ 40MG BASE/VIAL) submitted by Shuangcheng. The drug is categorized as therapeutically equivalent (TE Code AP), meaning it is substitutable for its reference listed drug. Marketing status is Prescription.

Manufacturers and distributors of competing Pantoprazole Sodium injectable products should be aware of this new market entrant. Healthcare providers and pharmacies gain an additional therapeutically equivalent generic option for this proton pump inhibitor formulation. The approval does not impose new compliance obligations on existing market participants.

Archived snapshot

Apr 24, 2026

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Abbreviated New Drug Application (ANDA): 219973
Company: SHUANGCHENG
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Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE;INTRAVENOUS Prescription AP 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
04/22/2026 ORIG-1 Approval STANDARD Label is not available on this site.

PANTOPRAZOLE SODIUM

INJECTABLE;INTRAVENOUS; EQ 40MG BASE/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE;INTRAVENOUS Prescription No AP 219230 ALEMBIC
PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE;INTRAVENOUS Prescription No AP 213778 ASPIRO
PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE;INTRAVENOUS Prescription No AP 216171 BE PHARMS
PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE;INTRAVENOUS Prescription No AP 215074 DEVA HOLDING AS
PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE;INTRAVENOUS Prescription No AP 079197 EPIC PHARMA LLC
PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE;INTRAVENOUS Prescription No AP 205675 EUGIA PHARMA
PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE;INTRAVENOUS Prescription No AP 204400 GLAND
PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE;INTRAVENOUS Prescription No AP 209524 HANGZHOU ZHONGMEI
PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE;INTRAVENOUS Prescription No AP 214680 KNACK
PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE;INTRAVENOUS Prescription No AP 215860 MEITHEAL
PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE;INTRAVENOUS Prescription No AP 219973 SHUANGCHENG
PROTONIX IV PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE;INTRAVENOUS Prescription Yes AP 020988 WYETH PHARMS

Mentioned entities

Food and Drug Administration

Parties

SHUANGCHENG

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Classification

Agency
FDA
Published
April 22nd, 2026
Instrument
Rule
Branch
Executive
Legal weight
Binding
Stage
Final
Change scope
Minor

Who this affects

Applies to
Pharmaceutical companies Drug manufacturers Healthcare providers
Industry sector
3254 Pharmaceutical Manufacturing
Activity scope
Generic drug approval Pharmaceutical manufacturing Drug distribution
Geographic scope
United States US

Taxonomy

Primary area
Pharmaceuticals
Operational domain
Regulatory Affairs
Compliance frameworks
GxP
Topics
Healthcare

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