Details for New Drug Application (NDA): 209204
✉ 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 209204
Tradename: | IBUPROFEN |
Applicant: | Taro |
Ingredient: | ibuprofen |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 209204
Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for 209204
Suppliers and Packaging for NDA: 209204
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
IBUPROFEN | ibuprofen | SUSPENSION;ORAL | 209204 | ANDA | Pharmaceutical Associates, Inc. | 0121-0918 | 0121-0918-40 | 4 TRAY in 1 CASE (0121-0918-40) / 10 PACKAGE in 1 TRAY / 1 mL in 1 PACKAGE (0121-0918-05) |
IBUPROFEN | ibuprofen | SUSPENSION;ORAL | 209204 | ANDA | Pharmaceutical Associates, Inc. | 0121-0918 | 0121-0918-50 | 5 TRAY in 1 CASE (0121-0918-50) / 10 PACKAGE in 1 TRAY / 1 mL in 1 PACKAGE (0121-0918-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;ORAL | Strength | 100MG/5ML | ||||
Approval Date: | Jun 23, 2017 | TE: | AB | RLD: | No |
Complete Access Available with Subscription