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| Last Updated on PharmaCompass | Virtual Booth | Country | Holder | DMF No. | Subject | Submission Date | Status | Type | GDUFA DMF Review | GDUFA Review Date | GDUFA Payment Date | 
|---|---|---|---|---|---|---|---|---|---|---|---|
| 31/10/2025 | Granules India Limited | 
						 India 					 | 
					GRANULES INDIA LTD | 22898 | LEVOCETIRIZINE DIHYDROCHLORIDE USP | 2009-05-22 | Active | II | Complete | 2022-03-09 | 2022-02-08 | 
| 31/10/2025 | Metrochem API Private Limited | 
						 India 					 | 
					METROCHEM API PRIVATE LTD | 34731 | LEVOCETIRIZINE DIHYDROCHLORIDE USP | 2020-05-12 | Active | II | N/A | 
