FdaApplication
ANDA 216082
Identifiers
- fda_app_no: ANDA216082
Properties
| Property | Value |
|---|---|
| applicant_name | GRANULES INDIA LTD |
| application_type | ANDA |
| approval_date | 2022-08-22 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE | 600MG;60MG | TABLET, EXTENDED RELEASE;ORAL |
| GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE | 1.2GM;120MG | TABLET, EXTENDED RELEASE;ORAL |
2 products