Details for New Drug Application (NDA): 209178
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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 209178
Tradename: | IBUPROFEN |
Applicant: | Aurobindo Pharma Ltd |
Ingredient: | ibuprofen |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 209178
Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for 209178
Suppliers and Packaging for NDA: 209178
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
IBUPROFEN | ibuprofen | SUSPENSION;ORAL | 209178 | ANDA | Aurobindo Pharma Limited | 59651-032 | 59651-032-12 | 1 BOTTLE in 1 CARTON (59651-032-12) / 120 mL in 1 BOTTLE |
IBUPROFEN | ibuprofen | SUSPENSION;ORAL | 209178 | ANDA | Aurobindo Pharma Limited | 59651-032 | 59651-032-47 | 1 BOTTLE in 1 CARTON (59651-032-47) / 473 mL in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;ORAL | Strength | 100MG/5ML | ||||
Approval Date: | Feb 16, 2018 | TE: | AB | RLD: | No |
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