Details for New Drug Application (NDA): 021373
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NDA 021373 describes CHILDREN'S ADVIL COLD, which is a drug marketed by Haleon Us Holdings and is included in one NDA. Additional details are available on the CHILDREN'S ADVIL COLD profile page.
The generic ingredient in CHILDREN'S ADVIL COLD is ibuprofen; pseudoephedrine hydrochloride. There are sixty-four drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the ibuprofen; pseudoephedrine hydrochloride profile page.
The generic ingredient in CHILDREN'S ADVIL COLD is ibuprofen; pseudoephedrine hydrochloride. There are sixty-four drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the ibuprofen; pseudoephedrine hydrochloride profile page.
Summary for 021373
| Tradename: | CHILDREN'S ADVIL COLD |
| Applicant: | Haleon Us Holdings |
| Ingredient: | ibuprofen; pseudoephedrine hydrochloride |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | SUSPENSION;ORAL | Strength | 100MG/5ML;15MG/5ML | ||||
| Approval Date: | Apr 18, 2002 | TE: | RLD: | No | |||||
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