Details for New Drug Application (NDA): 202413
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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 202413
Tradename: | IBUPROFEN |
Applicant: | Shandong Xinhua |
Ingredient: | ibuprofen |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 202413
Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for 202413
Suppliers and Packaging for NDA: 202413
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
IBUPROFEN | ibuprofen | TABLET;ORAL | 202413 | ANDA | Chartwell RX, LLC | 62135-400 | 62135-400-12 | 120 TABLET, FILM COATED in 1 PACKAGE (62135-400-12) |
IBUPROFEN | ibuprofen | TABLET;ORAL | 202413 | ANDA | Chartwell RX, LLC | 62135-401 | 62135-401-12 | 120 TABLET, FILM COATED in 1 PACKAGE (62135-401-12) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 400MG | ||||
Approval Date: | Nov 23, 2016 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 600MG | ||||
Approval Date: | Nov 23, 2016 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 800MG | ||||
Approval Date: | Nov 23, 2016 | TE: | AB | RLD: | No |
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