Application 209235
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE | IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE | CAPSULE;ORAL | EQ 200MG FREE ACID AND POTASSIUM SALT;30MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0363-1106 | Ibuprofen and Pseudoephedrine HCl | Ibuprofen and Pseudoephedrine HCl | WALGREEN CO. | ANDA | Current |
| 0363-1106 | Ibuprofen and Pseudoephedrine HCl | Ibuprofen and Pseudoephedrine HCl | WALGREEN CO. | ANDA | Current |
| 0363-1106 | Ibuprofen and Pseudoephedrine HCl | Ibuprofen and Pseudoephedrine HCl | WALGREEN CO. | ANDA | Current |
| 46122-609 | Ibuprofen and Pseudoephedrine HCl | Ibuprofen and Pseudoephedrine HCl | Amerisource Bergen | ANDA | Current |
| 46122-609 | Ibuprofen and Pseudoephedrine HCl | Ibuprofen and Pseudoephedrine HCl | Amerisource Bergen | ANDA | Current |
| 46122-609 | Ibuprofen and Pseudoephedrine HCl | Ibuprofen and Pseudoephedrine HCl | Amerisource Bergen | ANDA | Current |
| 58602-803 | Ibuprofen and Pseudoephedrine HCl | Ibuprofen and Pseudoephedrine HCl | Aurohealth LLC | ANDA | Current |
| 58602-803 | Ibuprofen and Pseudoephedrine HCl | Ibuprofen and Pseudoephedrine HCl | Aurohealth LLC | ANDA | Current |
| 58602-803 | Ibuprofen and Pseudoephedrine HCl | Ibuprofen and Pseudoephedrine HCl | Aurohealth LLC | ANDA | Current |
| 58602-803 | Ibuprofen and Pseudoephedrine HCl | Ibuprofen and Pseudoephedrine HCl | Aurohealth LLC | ANDA | Current |
| 58602-803 | Ibuprofen and Pseudoephedrine HCl | Ibuprofen and Pseudoephedrine HCl | Aurohealth LLC | ANDA | Current |
| 69842-092 | Ibuprofen and Pseudoephedrine HCl | Ibuprofen and Pseudoephedrine HCl | CVS Pharmacy, Inc. | ANDA | Current |
| 69842-092 | Ibuprofen and Pseudoephedrine HCl | Ibuprofen and Pseudoephedrine HCl | CVS Pharmacy, Inc. | ANDA | Current |
| 69842-092 | Ibuprofen and Pseudoephedrine HCl | Ibuprofen and Pseudoephedrine HCl | CVS Pharmacy, Inc. | ANDA | Current |
| 70000-0606 | Ibuprofen and Pseudoephedrine HCl | Ibuprofen and Pseudoephedrine HCl | Cardinal Health | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 50986 | ORIG | 2018-01-08 |