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Details for New Drug Application (NDA): 203791
NDA 203791 describes SITAVIG, which is a drug marketed by Epi Hlth and is included in one NDA. It is available from two suppliers. 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. Seventy-four suppliers are listed 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. Seventy-four suppliers are listed 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 |
Pharmacology for NDA: 203791
| Ingredient-type | Nucleoside Analog |
| Mechanism of Action | DNA Polymerase Inhibitors |
Medical Subject Heading (MeSH) Categories for 203791
Suppliers and Packaging for NDA: 203791
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SITAVIG | acyclovir | TABLET;BUCCAL | 203791 | NDA | Cipher Pharmaceuticals US LLC | 68712-049 | 68712-049-02 | 1 BLISTER PACK in 1 CARTON (68712-049-02) > 2 TABLET, DELAYED RELEASE in 1 BLISTER PACK |
| SITAVIG | acyclovir | TABLET;BUCCAL | 203791 | NDA | EPI Health, Inc | 71403-049 | 71403-049-01 | 1 BLISTER PACK in 1 CARTON (71403-049-01) > 2 TABLET, DELAYED RELEASE in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;BUCCAL | Strength | 50MG | ||||
| Approval Date: | Apr 12, 2013 | TE: | RLD: | Yes | |||||
| Patent: | ➤ Sign Up | Patent Expiration: | Jun 16, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF HERPES LABIALIS | ||||||||
| Patent: | ➤ Sign Up | Patent Expiration: | Jun 3, 2027 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF HERPES LABIALIS | ||||||||
| Patent: | ➤ Sign Up | Patent Expiration: | Mar 23, 2027 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF HERPES LABIALIS | ||||||||
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