Details for New Drug Application (NDA): 077309
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NDA 077309 describes ACYCLOVIR, which is a drug marketed by Actavis Elizabeth, Adaptis, Apotex, Aurobindo Pharma Usa, Cadila, Cadila Pharms Ltd, Carlsbad Technology, Chartwell Molecules, Heritage, Ivax Sub Teva Pharms, Lek Pharm, Mylan, Ranbaxy, Roxane, Strides Pharma, Teva, Teva Pharms, Watson Labs, Yiling, Alembic, Amneal, Padagis Israel, Taro, Zydus Lifesciences, Abbvie, Amneal Pharms, Anda Repository, Chartwell Rx, Cipla, Cosette, Fougera Pharms Inc, Glenmark Speclt, Macleods Pharms Ltd, Mylan Pharms Inc, Prinston Inc, Torrent, Xiromed, Actavis Mid Atlantic, Aurobindo Pharma, Hetero Labs Ltd Iii, Hikma, MSN, Novitium Pharma, Rubicon, Vistapharm Llc, Apotex Inc, Carlsbad, Hetero Labs Ltd V, Square Pharms, Sun Pharm Inds Ltd, Zydus Pharms, Eurohlth Intl Sarl, Apothecon, Chartwell Injectable, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Hospira, Norvium Bioscience, Slate Run Pharma, and Teva Parenteral, and is included in ninety NDAs. It is available from sixty-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. Nine 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. Nine suppliers are listed for this compound. Additional details are available on the acyclovir sodium profile page.
Summary for 077309
| Tradename: | ACYCLOVIR |
| Applicant: | Apotex Inc |
| Ingredient: | acyclovir |
| Patents: | 0 |
Pharmacology for NDA: 077309
| Mechanism of Action | DNA Polymerase Inhibitors |
Medical Subject Heading (MeSH) Categories for 077309
Suppliers and Packaging for NDA: 077309
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ACYCLOVIR | acyclovir | TABLET;ORAL | 077309 | ANDA | Major Pharmaceuticals | 0904-5790 | 0904-5790-61 | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (0904-5790-61) / 1 TABLET in 1 BLISTER PACK |
| ACYCLOVIR | acyclovir | TABLET;ORAL | 077309 | ANDA | Lake Erie Medical DBA Quality Care Products LLC | 35356-903 | 35356-903-40 | 40 TABLET in 1 BOTTLE (35356-903-40) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 400MG | ||||
| Approval Date: | Sep 29, 2005 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 800MG | ||||
| Approval Date: | Sep 29, 2005 | TE: | AB | RLD: | No | ||||
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