Details for New Drug Application (NDA): 206568
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The generic ingredient in IBUPROFEN is ibuprofen sodium. There are sixty-four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ibuprofen sodium profile page.
Summary for 206568
Tradename: | IBUPROFEN |
Applicant: | Humanwell Puracap |
Ingredient: | ibuprofen |
Patents: | 0 |
Pharmacology for NDA: 206568
Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for 206568
Suppliers and Packaging for NDA: 206568
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
IBUPROFEN | ibuprofen | CAPSULE;ORAL | 206568 | ANDA | Walgreens | 0363-0743 | 0363-0743-20 | 1 BOTTLE, PLASTIC in 1 BOX (0363-0743-20) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC |
IBUPROFEN | ibuprofen | CAPSULE;ORAL | 206568 | ANDA | Walgreens | 0363-0743 | 0363-0743-80 | 1 BOTTLE, PLASTIC in 1 BOX (0363-0743-80) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC |
Profile for product number 001
Active Rx/OTC/Discontinued: | OTC | Dosage: | CAPSULE;ORAL | Strength | EQ 200MG FREE ACID AND POTASSIUM SALT | ||||
Approval Date: | Jun 21, 2016 | TE: | RLD: | No |
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