Details for New Drug Application (NDA): 091480
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NDA 091480 describes FAMCICLOVIR, which is a drug marketed by Apotex, Aurobindo Pharma Ltd, Cipla, Hetero Labs Ltd V, Hikma, Macleods Pharms Ltd, Natco Pharma, and Teva Pharms, and is included in eight NDAs. It is available from ten suppliers. Additional details are available on the FAMCICLOVIR profile page.
The generic ingredient in FAMCICLOVIR is famciclovir. There are eight drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the famciclovir profile page.
The generic ingredient in FAMCICLOVIR is famciclovir. There are eight drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the famciclovir profile page.
Summary for 091480
| Tradename: | FAMCICLOVIR |
| Applicant: | Apotex |
| Ingredient: | famciclovir |
| Patents: | 0 |
Pharmacology for NDA: 091480
| Mechanism of Action | DNA Polymerase Inhibitors |
Suppliers and Packaging for NDA: 091480
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FAMCICLOVIR | famciclovir | TABLET;ORAL | 091480 | ANDA | Apotex Corp. | 60505-3245 | 60505-3245-3 | 30 TABLET, FILM COATED in 1 BOTTLE (60505-3245-3) |
| FAMCICLOVIR | famciclovir | TABLET;ORAL | 091480 | ANDA | Apotex Corp. | 60505-3246 | 60505-3246-3 | 30 TABLET, FILM COATED in 1 BOTTLE (60505-3246-3) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 125MG | ||||
| Approval Date: | Jul 22, 2011 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 250MG | ||||
| Approval Date: | Jul 22, 2011 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
| Approval Date: | Jul 22, 2011 | TE: | AB | RLD: | No | ||||
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