| Product NDC: | 62756-915 |
| Proprietary Name: | Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride |
| Non Proprietary Name: | Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride |
| Active Ingredient(s): | 5; 120 mg/1; mg/1 & nbsp; Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride |
| Administration Route(s): | ORAL |
| Dosage Form(s): | TABLET, FILM COATED, EXTENDED RELEASE |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 62756-915 |
| Labeler Name: | Sun Pharmaceutical Industries Limited |
| Product Type: | HUMAN OTC DRUG |
| FDA Application Number: | ANDA090922 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20120929 |
| Package NDC: | 62756-915-83 |
| Package Description: | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62756-915-83) |
| NDC Code | 62756-915-83 |
| Proprietary Name | Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride |
| Package Description | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62756-915-83) |
| Product NDC | 62756-915 |
| Product Type Name | HUMAN OTC DRUG |
| Non Proprietary Name | Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride |
| Dosage Form Name | TABLET, FILM COATED, EXTENDED RELEASE |
| Route Name | ORAL |
| Start Marketing Date | 20120929 |
| Marketing Category Name | ANDA |
| Labeler Name | Sun Pharmaceutical Industries Limited |
| Substance Name | CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE |
| Strength Number | 5; 120 |
| Strength Unit | mg/1; mg/1 |
| Pharmaceutical Classes |