NDA (New Drug Application)
ANDA (Generic Application)
It is formulated by 15 pharmaceutical companies such as TEVA PHARMS, AUROBINDO PHARMA, CHARTWELL RX and others. It is marketed under 1 brand name, including VALACYCLOVIR HYDROCHLORIDE. Available in 2 different strengths, such as EQ 1GM BASE, EQ 500MG BASE, and administered through 1 route including TABLET;ORAL.
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FDA approval history for this ingredient
Key expiration dates for US patents covering this ingredient
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
No US Orange Book patents found
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
Note: Patent expirations and exclusivity timelines are dynamic and may shift based on litigation, regulatory extensions, and maintenance filings. Regular monitoring is advised.