Details for New Drug Application (NDA): 079113
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NDA 079113 describes IBUPROFEN AND DIPHENHYDRAMINE CITRATE, which is a drug marketed by Aurobindo Pharma, Dr Reddys Labs Ltd, Perrigo R And D, and Pld Acquisitions Llc, and is included in four NDAs. It is available from twenty-eight suppliers. Additional details are available on the IBUPROFEN AND DIPHENHYDRAMINE CITRATE profile page.
The generic ingredient in IBUPROFEN AND DIPHENHYDRAMINE CITRATE is diphenhydramine citrate; ibuprofen. There are twenty-three drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the diphenhydramine citrate; ibuprofen profile page.
The generic ingredient in IBUPROFEN AND DIPHENHYDRAMINE CITRATE is diphenhydramine citrate; ibuprofen. There are twenty-three drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the diphenhydramine citrate; ibuprofen profile page.
Summary for 079113
| Tradename: | IBUPROFEN AND DIPHENHYDRAMINE CITRATE |
| Applicant: | Perrigo R And D |
| Ingredient: | diphenhydramine citrate; ibuprofen |
| Patents: | 0 |
Pharmacology for NDA: 079113
| Mechanism of Action | Cyclooxygenase Inhibitors Histamine H1 Receptor Antagonists |
Suppliers and Packaging for NDA: 079113
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| IBUPROFEN AND DIPHENHYDRAMINE CITRATE | diphenhydramine citrate; ibuprofen | TABLET;ORAL | 079113 | ANDA | L. Perrigo Company | 0113-0050 | 0113-0050-58 | 1 BOTTLE in 1 CARTON (0113-0050-58) / 40 TABLET, FILM COATED in 1 BOTTLE |
| IBUPROFEN AND DIPHENHYDRAMINE CITRATE | diphenhydramine citrate; ibuprofen | TABLET;ORAL | 079113 | ANDA | L. Perrigo Company | 0113-0050 | 0113-0050-60 | 1 BOTTLE in 1 CARTON (0113-0050-60) / 20 TABLET, FILM COATED in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 38MG;200MG | ||||
| Approval Date: | Dec 22, 2008 | TE: | RLD: | No | |||||
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