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Details for New Drug Application (NDA): 203791
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NDA 203791 describes SITAVIG, which is a drug marketed by Epi Hlth and is included in one NDA. There are three patents protecting this drug. Additional details are available on the SITAVIG profile page.
The generic ingredient in SITAVIG is acyclovir. There are fifty-six drug master file entries for this compound. Additional details are available on the acyclovir profile page.
The generic ingredient in SITAVIG is acyclovir. There are fifty-six drug master file entries for this compound. Additional details are available on the acyclovir profile page.
Summary for 203791
| Tradename: | SITAVIG |
| Applicant: | Epi Hlth |
| Ingredient: | acyclovir |
| Patents: | 3 |
| Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 203791
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;BUCCAL | Strength | 50MG | ||||
| Approval Date: | Apr 12, 2013 | TE: | RLD: | Yes | |||||
| Patent: | Start Trial | Patent Expiration: | Jun 16, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | Start Trial | Patent Expiration: | Jun 3, 2027 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | Start Trial | Patent Expiration: | Mar 23, 2027 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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