Details for New Drug Application (NDA): 210676
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NDA 210676 describes IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE, which is a drug marketed by Aurobindo Pharma Ltd, Bionpharma, and Strides Pharma, and is included in three NDAs. It is available from sixteen suppliers. Additional details are available on the IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE profile page.
The generic ingredient in IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE is diphenhydramine hydrochloride; ibuprofen. There are twenty-three drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the diphenhydramine hydrochloride; ibuprofen profile page.
The generic ingredient in IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE is diphenhydramine hydrochloride; ibuprofen. There are twenty-three drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the diphenhydramine hydrochloride; ibuprofen profile page.
Summary for 210676
| Tradename: | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE |
| Applicant: | Aurobindo Pharma Ltd |
| Ingredient: | diphenhydramine hydrochloride; ibuprofen |
| Patents: | 0 |
Pharmacology for NDA: 210676
| Mechanism of Action | Cyclooxygenase Inhibitors Histamine H1 Receptor Antagonists |
Suppliers and Packaging for NDA: 210676
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | diphenhydramine hydrochloride; ibuprofen | CAPSULE;ORAL | 210676 | ANDA | Walgreens | 0363-0250 | 0363-0250-40 | 1 BOTTLE, PLASTIC in 1 BOX (0363-0250-40) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC |
| IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | diphenhydramine hydrochloride; ibuprofen | CAPSULE;ORAL | 210676 | ANDA | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 55910-125 | 55910-125-20 | 1 BOTTLE, PLASTIC in 1 BOX (55910-125-20) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | CAPSULE;ORAL | Strength | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | ||||
| Approval Date: | Feb 14, 2019 | TE: | RLD: | No | |||||
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