PHPMaker 2020
Human Drugs
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Human Drugs
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Product Information
Registration Number
DRP-8477-02
Generic Name
Hyoscine N-Butylbromide
Brand Name
Spalax
Dosage Strength
10 mg
Dosage Form
Film-Coated Tablet
Classification
Prescription Drug (Rx)
Pharmacologic Category
Anticholinergic
Packaging
Alu/PVC Blister pack x 10’s (Box of 50’s) Alu/PVC Blister pack x 10’s (Box of 100’s)
Manufacturer
Sapphire Lifesciences Pvt. Ltd.
Country of Origin
India
Trader
N/A
Importer
Nelpa Lifesciences, Inc
Distributor
Kaufmann Pharma Inc
Application Type
CLIDP Conversion
Issuance Date
26 September 2023
Expiry Date
16 May 2027
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