Details for New Drug Application (NDA): 090619
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NDA 090619 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 090619
| Tradename: | IBUPROFEN AND DIPHENHYDRAMINE CITRATE |
| Applicant: | Dr Reddys Labs Ltd |
| Ingredient: | diphenhydramine citrate; ibuprofen |
| Patents: | 0 |
Pharmacology for NDA: 090619
| Mechanism of Action | Cyclooxygenase Inhibitors Histamine H1 Receptor Antagonists |
Suppliers and Packaging for NDA: 090619
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| IBUPROFEN AND DIPHENHYDRAMINE CITRATE | diphenhydramine citrate; ibuprofen | TABLET;ORAL | 090619 | ANDA | Dr. Reddy's Laboratories Limited | 55111-565 | 55111-565-05 | 1 BOTTLE in 1 CARTON (55111-565-05) / 500 TABLET in 1 BOTTLE |
| IBUPROFEN AND DIPHENHYDRAMINE CITRATE | diphenhydramine citrate; ibuprofen | TABLET;ORAL | 090619 | ANDA | Dr. Reddy's Laboratories Limited | 55111-565 | 55111-565-14 | 1 BOTTLE in 1 CARTON (55111-565-14) / 20 TABLET in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 38MG;200MG | ||||
| Approval Date: | Jul 8, 2009 | TE: | RLD: | No | |||||
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