Details for New Drug Application (NDA): 205510
NDA 205510 describes ACYCLOVIR, which is a drug marketed by Actavis Elizabeth, Apotex, Aurobindo Pharma Usa, Cadila, Cadila Pharms Ltd, Carlsbad, Chartwell Molecules, Heritage, Ivax Sub Teva Pharms, Lek Pharm, Mylan, Pharmobedient, Ranbaxy, Regcon Holdings, Roxane, Strides Pharma Intl, Teva, Teva Pharms, Watson Labs, Alembic, Amneal, Cipla, Padagis Israel, Sun Pharma Canada, Zydus Lifesciences, Abbvie, Amneal Pharms, Chartwell Molecular, Chartwell Rx, Cosette Pharms Nc, Fougera Pharms Inc, Glenmark Speclt, Macleods Pharms, Prinston Inc, Torrent, Xiromed, Actavis Mid Atlantic, Aurobindo Pharma, Hetero Labs Ltd Iii, Hikma, MSN, Novitium Pharma, Rubicon Research, Vistapharm Llc, Adaptis, Hetero Labs Ltd V, Sun Pharm Inds Ltd, Zydus Pharms, Eurohlth Intl Sarl, Apothecon, Chartwell Injectable, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Hainan Poly, Hospira, and Teva Parenteral, and is included in ninety-one NDAs. It is available from sixty suppliers. Additional details are available on the ACYCLOVIR profile page.
The generic ingredient in ACYCLOVIR is acyclovir sodium. There are two drug master file entries for this compound. Eight 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 two drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the acyclovir sodium profile page.
Summary for 205510
| Tradename: | ACYCLOVIR |
| Applicant: | Glenmark Speclt |
| Ingredient: | acyclovir |
| Patents: | 0 |
Pharmacology for NDA: 205510
| Mechanism of Action | DNA Polymerase Inhibitors |
Medical Subject Heading (MeSH) Categories for 205510
Suppliers and Packaging for NDA: 205510
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ACYCLOVIR | acyclovir | OINTMENT;TOPICAL | 205510 | ANDA | Northstar Rx LLC | 16714-885 | 16714-885-01 | 1 TUBE in 1 CARTON (16714-885-01) / 15 g in 1 TUBE |
| ACYCLOVIR | acyclovir | OINTMENT;TOPICAL | 205510 | ANDA | Northstar Rx LLC | 16714-885 | 16714-885-02 | 1 TUBE in 1 CARTON (16714-885-02) / 30 g in 1 TUBE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | OINTMENT;TOPICAL | Strength | 5% | ||||
| Approval Date: | Jul 31, 2017 | TE: | AB | RLD: | No | ||||
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