Details for New Drug Application (NDA): 205974
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NDA 205974 describes ACYCLOVIR, which is a drug marketed by Actavis Elizabeth, Apotex, Aurobindo Pharma Usa, Cadila, Cadila Pharms Ltd, Carlsbad Technology, Chartwell Molecules, Heritage, Ivax Sub Teva Pharms, Lek Pharm, Mylan, Ranbaxy, Regcon Holdings, Roxane, Strides Pharma Intl, Teva, Teva Pharms, Watson Labs, Yiling, Alembic, Amneal, Cipla, Padagis Israel, Sun Pharma Canada, Zydus Lifesciences, Abbvie, Amneal Pharms, Chartwell Molecular, Chartwell Rx, Cosette, Fougera Pharms Inc, Glenmark Speclt, Macleods Pharms Ltd, Pharmobedient, Prinston Inc, Torrent, Xiromed, Actavis Mid Atlantic, Aurobindo Pharma, Hetero Labs Ltd Iii, Hikma, MSN, Novitium Pharma, Rubicon Research, Vistapharm Llc, 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, Slate Run Pharma, and Teva Parenteral, and is included in ninety-one NDAs. It is available from fifty-nine 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. 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 fifty-six 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 205974
| Tradename: | ACYCLOVIR |
| Applicant: | Zydus Lifesciences |
| Ingredient: | acyclovir |
| Patents: | 0 |
Pharmacology for NDA: 205974
| Mechanism of Action | DNA Polymerase Inhibitors |
Medical Subject Heading (MeSH) Categories for 205974
Suppliers and Packaging for NDA: 205974
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ACYCLOVIR | acyclovir | OINTMENT;TOPICAL | 205974 | ANDA | Preferred Pharmaceuticals Inc | 68788-8247 | 68788-8247-1 | 1 TUBE in 1 CARTON (68788-8247-1) / 15 g in 1 TUBE |
| ACYCLOVIR | acyclovir | OINTMENT;TOPICAL | 205974 | ANDA | Zydus Lifesciences Limited | 70771-1371 | 70771-1371-1 | 1 TUBE in 1 CARTON (70771-1371-1) / 15 g in 1 TUBE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | OINTMENT;TOPICAL | Strength | 5% | ||||
| Approval Date: | Mar 15, 2019 | TE: | AB | RLD: | No | ||||
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