Details for New Drug Application (NDA): 213794
✉ Email this page to a colleague
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 213794
Tradename: | IBUPROFEN |
Applicant: | Aurobindo Pharma Ltd |
Ingredient: | ibuprofen |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 213794
Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for 213794
Suppliers and Packaging for NDA: 213794
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
IBUPROFEN | ibuprofen | TABLET;ORAL | 213794 | ANDA | A-S Medication Solutions | 50090-5437 | 50090-5437-0 | 30 TABLET in 1 BOTTLE (50090-5437-0) |
IBUPROFEN | ibuprofen | TABLET;ORAL | 213794 | ANDA | A-S Medication Solutions | 50090-5444 | 50090-5444-4 | 28 TABLET in 1 BOTTLE (50090-5444-4) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 400MG | ||||
Approval Date: | May 8, 2020 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 600MG | ||||
Approval Date: | May 8, 2020 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 800MG | ||||
Approval Date: | May 8, 2020 | TE: | AB | RLD: | No |
Complete Access Available with Subscription