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Details for New Drug Application (NDA): 204314
NDA 204314 describes ACYCLOVIR, which is a drug marketed by Actavis Elizabeth, Apotex Inc, Boscogen, Cadila Pharms Ltd, Carlsbad Technology, Chartwell Molecules, Dava Pharms Inc, Heritage Pharms Inc, Ivax Sub Teva Pharms, Lek Pharm, Mylan, Ranbaxy, Roxane, Teva, Teva Pharms, Watson Labs, Zydus Pharms Usa Inc, Abbvie, Alembic Pharms Ltd, Amneal Pharms, Fougera Pharms Inc, G And W Labs Inc, Glenmark Pharms Ltd, Mylan Pharms Inc, Taro, Tolmar, Actavis Mid Atlantic, Hi Tech Pharma, Carlsbad, Hetero Labs Ltd V, Sun Pharm Inds Ltd, Yiling Pharm Ltd, Eurohlth Intl Sarl, Apothecon, Athenex Inc, Aurobindo Pharma Ltd, Fresenius Kabi Usa, Hikma Pharms, Hospira, Mylan Labs Ltd, and Teva Parenteral, and is included in sixty-three NDAs. It is available from fifty-eight suppliers. Additional details are available on the ACYCLOVIR profile page.
The generic ingredient in ACYCLOVIR is acyclovir sodium. There are fifty-six drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the acyclovir sodium profile page.
The generic ingredient in ACYCLOVIR is acyclovir sodium. There are fifty-six drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the acyclovir sodium profile page.
Summary for 204314
| Tradename: | ACYCLOVIR |
| Applicant: | Zydus Pharms Usa Inc |
| Ingredient: | acyclovir |
| Patents: | 0 |
| Therapeutic Class: | Antivirals |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 204314
| Ingredient-type | Nucleoside Analog |
| Mechanism of Action | DNA Polymerase Inhibitors |
Medical Subject Heading (MeSH) Categories for 204314
Suppliers and Packaging for NDA: 204314
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ACYCLOVIR | acyclovir | TABLET;ORAL | 204314 | ANDA | Unit Dose Services | 50436-0792 | N | 50436-0792-1 |
| ACYCLOVIR | acyclovir | TABLET;ORAL | 204314 | ANDA | Aidarex Pharmaceuticals LLC | 53217-188 | N | 53217-188-25 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 400MG | ||||
| Approval Date: | Aug 19, 2014 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 800MG | ||||
| Approval Date: | Aug 19, 2014 | TE: | AB | RLD: | No | ||||
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