Details for New Drug Application (NDA): 202300
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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 202300
Tradename: | IBUPROFEN |
Applicant: | Amneal Pharms |
Ingredient: | ibuprofen |
Patents: | 0 |
Pharmacology for NDA: 202300
Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for 202300
Suppliers and Packaging for NDA: 202300
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
IBUPROFEN | ibuprofen | CAPSULE;ORAL | 202300 | ANDA | The Kroger Co. | 30142-728 | 30142-728-80 | 1 BOTTLE, PLASTIC in 1 BOX (30142-728-80) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC |
IBUPROFEN | ibuprofen | CAPSULE;ORAL | 202300 | ANDA | H E B | 37808-221 | 37808-221-20 | 1 BOTTLE, PLASTIC in 1 BOX (37808-221-20) / 20 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: | Dec 23, 2011 | TE: | RLD: | No |
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