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Lupin Gets Tentative USFDA Approval for Apixaban Oral Suspension

The oral liquid formulation offers an alternative for adults who have difficulty swallowing tablets and will be made at Lupin’s New Jersey plant.

Summary by Medical Dialogues
Mumbai: Lupin Limited has received tentative approval from the United States Food and Drug Administration (USFDA) for its New Drug Application (NDA) for Apixaban Oral Suspension 1.25 mg/mL under the...

7 Articles

The HinduThe Hindu
Lean Left

Lupin gets U.S. FDA tentative nod for Apixaban Oral Suspension

The approval was obtained through the 505(b)(2),

·Chennai, India
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PR NewswirePR Newswire
Reposted by
Medical Device News MagazineMedical Device News Magazine
Center

Lupin Receives Tentative Approval from U.S. FDA for Novel Apixaban Oral Suspension

/PRNewswire/ -- Global pharmaceutical leader Lupin Limited (Lupin) (BSE: 500257) (NSE: LUPIN) (REUTERS: LUPIN.BO) (BLOOMBERG: LPCIN) today announced that it...

·Chicago, United States
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Medical DialoguesMedical Dialogues
Reposted by
equitypandit.comequitypandit.com
Center

Lupin Gets Tentative USFDA Approval for Apixaban Oral Suspension

Mumbai: Lupin Limited has received tentative approval from the United States Food and Drug Administration (USFDA) for its New Drug Application (NDA) for Apixaban Oral Suspension 1.25 mg/mL under the...

·New Delhi, India
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CDR – Chain Drug ReviewCDR – Chain Drug Review

Lupin gets tentative FDA Approval for novel Apixaban Oral Suspension

After final approval, Lupin will manufacture the product at its Somerset, New Jersey, facility.

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Express PharmaExpress Pharma

Lupin receives tentative approval from US FDA for novel Apixaban Oral Suspension

Global pharma major, Lupin announced that it has received tentative approval from the United States Food and Drug Administration (US FDA) for its New Drug Application for Apixaban Oral Suspension […]

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Express Pharma broke the news on Monday, September 28, 2026.
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