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New Drug for Migraine Approved

New Drug for Migraine Approved by Colleen Fleiss on February 25, 2021 at 8:03 AM The US Food & Drug Administration (US FDA) has approved Granules Abbreviated New Drug Application (ANDA) for acetaminophen, aspirin, and caffeine tablets, indicated for the treatment of migraine. It is bioequivalent to the Reference Listed Drug (RLD) product, Excedrin Migraine tablets, 250 mg/250 mg/65 mg, of GlaxoSmithKline Consumer Healthcare. The product would be manufactured at Granules India s Hyderabad facility and is expected to be launched shortly. ‘Granules Abbreviated New Drug Application (ANDA) for acetaminophen, aspirin, and caffeine tablets, indicated for migraine treatment has been approved by USFDA. ’ We are pleased to announce approval of Acetaminophen, Aspirin and Caffeine tablets, emphasising our focus on building a sustainable OTC product portfolio in the US market. We received approval for this triple combination product within 14 months from fi

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Strides Pharma Science arm gets USFDA nod for Ibuprofen OTC Oral Suspension

Strides Pharma Science arm gets USFDA nod for Ibuprofen OTC Oral Suspension
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Strides Pharma receives approval for ibuprofen from USFDA

Uniindia: Bengaluru, Feb 24 (UNI) Strides Pharma Science Limited (Strides), wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received approval for Ibuprofen Oral Suspension USP,100 mg/5 mL (OTC) from the United States Food & Drug Administration (USFDA).

Johnson consumer incStrides pharma science limitedUnited states food drug administrationStrides pharma globalIbuprofen oral suspensionUnited states foodDrug administrationReference listed drugOral suspensionஜான்சன் நுகர்வோர் இன்க்முன்னேற்றங்கள் பார்மா அறிவியல் வரையறுக்கப்பட்டவைமுன்னேற்றங்கள் பார்மா உலகளாவியஒன்றுபட்டது மாநிலங்களில் உணவுகுறிப்பு பட்டியலிடப்பட்டுள்ளது மருந்துவாய்வழி இடைநீக்கம்

Strides Pharma Science receives USFDA approval for Ibuprofen Oral Suspension

Strides Pharma Science announced that its step-down wholly owned subsidiary, Strides Pharma Global, Singapore, has received approval for Ibuprofen Oral Suspension USP,100 mg/5 mL (OTC) from the United States Food & Drug Administration (USFDA). The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Children s Motrin Oral Suspension, 100 mg/mL, of Johnson & Johnson Consumer Inc. Strides is focusing on building a private label business in the US by leveraging its portfolio of products across soft gels, tablets, capsules, topicals, powders and oral solutions. Ibuprofen Oral Suspension USP,100 mg/5 mL (OTC) further strengthens company s private label portfolio for the US market. According to IRi data, the US market for Ibuprofen Oral Suspension USP,100 mg/5 mL (OTC) is

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USFDA approves Granules drug for migraine

USFDA approves Granules drug for migraine By IANS | Published on Wed, Feb 24 2021 20:36 IST | 0 Views Migraine Attack (Photo: Pixabay). Image Source: IANS News Hyderabad, Feb 24 : Granules India Ltd on Wednesday announced that the US Food & Drug Administration (US FDA) has approved its Abbreviated New Drug Application (ANDA) for acetaminophen, aspirin, and caffeine tablets, indicated for the treatment of migraine. It is bioequivalent to the Reference Listed Drug (RLD) product, Excedrin Migraine tablets, 250 mg/250 mg/65 mg, of GlaxoSmithKline Consumer Healthcare. The product would be manufactured at Granules India s Hyderabad facility and is expected to be launched shortly. We are pleased to announce approval of Acetaminophen, Aspirin and Caffeine tablets, emphasising our focus on building a sustainable OTC product portfolio in the US market. We received approval for this triple combination product within 14 months from filing. With this, we have receiv

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