NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 2 pharmaceutical companies such as AMNEAL, PADAGIS US. It is marketed under 1 brand name, including TOBRAMYCIN AND DEXAMETHASONE. Available in 1 different strength, such as 0.1%;0.3%, and administered through 1 route including SUSPENSION/DROPS;OPHTHALMIC.
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FDA approval history for this ingredient
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Key expiration dates for US patents covering this ingredient
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Latest drug strengths approved by FDA
| Strength | Route of Administration | Companies | Latest Approval Date |
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Patents approved by the FDA for the ingredient
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Patent Number | Publication Date | Legal Status | Patent Expiry Date | |
|---|---|---|---|---|---|
| {"application_id":"82526","ingredient":"DEXAMETHASONE; TOBRAMYCIN","trade_name":"TOBRADEX ST","family_id":"5bf41f458b694641848e","publication_number":"US8101582B2","cleaned_patent_number":"8101582","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-12-19","publication_date":"2012-01-24","legal_status":"Granted"} | US8101582B2 Formulation | 24 Jan, 2012 | Granted | 19 Dec, 2027 | |
| {"application_id":"82528","ingredient":"DEXAMETHASONE; TOBRAMYCIN","trade_name":"TOBRADEX ST","family_id":"5bf41f458b694641848e","publication_number":"US8450287B2","cleaned_patent_number":"8450287","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-12-19","publication_date":"2013-05-28","legal_status":"Granted"} | US8450287B2 Formulation | 28 May, 2013 | Granted | 19 Dec, 2027 | |
| {"application_id":"82527","ingredient":"DEXAMETHASONE; TOBRAMYCIN","trade_name":"TOBRADEX ST","family_id":"5bf41f458b694641848e","publication_number":"US7795316B1","cleaned_patent_number":"7795316","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-08-03","publication_date":"2010-09-14","legal_status":"Patented case"} | US7795316B2 Formulation | 14 Sep, 2010 | Patented case | 03 Aug, 2028 |
Latest clinical trials and research studies for this ingredient
| NCT ID | Title | Status | Phase | Conditions | Start Date | Completion Date |
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Manufacturing Locations
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Note: Patent expirations and exclusivity timelines are dynamic and may shift based on litigation, regulatory extensions, and maintenance filings. Regular monitoring is advised.