Details for New Drug Application (NDA): 203200
✉ Email this page to a colleague
NDA 203200 describes IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE, which is a drug marketed by Perrigo R And D and is included in one NDA. It is available from five suppliers. Additional details are available on the IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE profile page.
The generic ingredient in IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE is ibuprofen; phenylephrine hydrochloride. There are sixty-four drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the ibuprofen; phenylephrine hydrochloride profile page.
The generic ingredient in IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE is ibuprofen; phenylephrine hydrochloride. There are sixty-four drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the ibuprofen; phenylephrine hydrochloride profile page.
Summary for 203200
| Tradename: | IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE |
| Applicant: | Perrigo R And D |
| Ingredient: | ibuprofen; phenylephrine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 203200
| Mechanism of Action | Adrenergic alpha1-Agonists Cyclooxygenase Inhibitors |
Suppliers and Packaging for NDA: 203200
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE | ibuprofen; phenylephrine hydrochloride | TABLET;ORAL | 203200 | ANDA | Rite Aid Corporation | 11822-5158 | 11822-5158-0 | 20 BLISTER PACK in 1 CARTON (11822-5158-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK |
| IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE | ibuprofen; phenylephrine hydrochloride | TABLET;ORAL | 203200 | ANDA | H E B | 37808-158 | 37808-158-60 | 20 BLISTER PACK in 1 CARTON (37808-158-60) / 1 TABLET, FILM COATED in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 200MG;10MG | ||||
| Approval Date: | Jul 3, 2014 | TE: | RLD: | No | |||||
Complete Access Available with Subscription
