Details for New Drug Application (NDA): 074937
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The generic ingredient in CHILDREN'S IBUPROFEN is ibuprofen. There are sixty-four drug master file entries for this compound. Two hundred and thirty-nine suppliers are listed for this compound. Additional details are available on the ibuprofen profile page.
Summary for 074937
Tradename: | CHILDREN'S IBUPROFEN |
Applicant: | Perrigo |
Ingredient: | ibuprofen |
Patents: | 0 |
Pharmacology for NDA: 074937
Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for 074937
Suppliers and Packaging for NDA: 074937
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CHILDREN'S IBUPROFEN | ibuprofen | SUSPENSION;ORAL | 074937 | ANDA | L. Perrigo Company | 0113-0166 | 0113-0166-26 | 1 BOTTLE in 1 CARTON (0113-0166-26) / 120 mL in 1 BOTTLE |
CHILDREN'S IBUPROFEN | ibuprofen | SUSPENSION;ORAL | 074937 | ANDA | L. Perrigo Company | 0113-0166 | 0113-0166-28 | 1 BOTTLE in 1 CARTON (0113-0166-28) / 150 mL in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | OTC | Dosage: | SUSPENSION;ORAL | Strength | 100MG/5ML | ||||
Approval Date: | Dec 22, 1998 | TE: | RLD: | No |
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