Chlorpheniramine / Ibuprofen / Phenylephrine Oral Tablet
- Category(s)
- otc
- SPL Type(s)
- Human OTC
- Master SPL
- Pfizer Consumer Healthcare (2014-12-29)
- Oldest Current Product
- 2012-07-23
- License(s)
- NDA
- RxNORM
- ORAL TABLET\CHLORPHENIRAMINE:IBUPROFEN:PHENYLEPHRINE
- FDAOB
- ORAL\TABLET\CHLORPHENIRAMINE MALEATE: IBUPROFEN: PHENYLEPHRINE HYDROCHLORIDE
- SPL Active
- ORAL\TABLET, COATED\CHLORPHENIRAMINE MALEATE: IBUPROFEN: PHENYLEPHRINE HYDROCHLORIDE
- SPL Moiety
- ORAL\TABLET, COATED\CHLORPHENIRAMINE: IBUPROFEN: PHENYLEPHRINE
product(s) by strength(s)
chlorpheniramine maleate 4 mg / ibuprofen 200 mg / phenylephrine hydrochloride 10 mg oral tablet
original product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 005730196 | NDA | Pfizer Consumer Healthcare | 2012-07-23 | CHLORPHENIRAMINE MALEATE, IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDE | ORAL | TABLET, COATED | NDA022113 | a6cc97d8-252a-4527-a470-6d9e356342fd |
application(s)
| # | id | title | applicant | approved | approved drug |
|---|---|---|---|---|---|
| 1 | NDA022113 | ADVIL ALLERGY AND CONGESTION RELIEF | PFIZER INC | 2011-12-21 | NDA022113_001 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | route | dose form | rld | approved | application |
|---|---|---|---|---|---|---|---|---|
| 1 | NDA022113_001 | OTC | IBUPROFEN (200MG), PHENYLEPHRINE HYDROCHLORIDE (10MG), CHLORPHENIRAMINE MALEATE (4MG) | ORAL | TABLET | True | 2011-12-21 | ADVIL ALLERGY AND CONGESTION RELIEF |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|---|
| 1 | a6cc97d8-252a-4527-a470-6d9e356342fd (view SPL) | Advil ALLERGY & CONGESTION RELIEF | otc | Human OTC | Pfizer Consumer Healthcare | ANALYSIS, LABEL, MANUFACTURE, PACK | 2014-12-29 | 4 | 005730196 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII