FDA Orange Book · active-ingredient family
Acyclovir sodium
Acyclovir sodium is approved as 1 brand and 21 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:ZOVIRAX · NDA 018603
1
Brand (NDA)
21
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ZOVIRAXRLD×3 | GLAXOSMITHKLINE | NDA 018603 | — | Jun 29, 1989 |
Generic (ANDA) products (21)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ACYCLOVIR SODIUM | FRESENIUS KABI USA | ANDA 215404 | AP | Jun 25, 2024 | |
| ACYCLOVIR SODIUM | SLATE RUN PHARMA | ANDA 218111 | AP | Jan 08, 2024 | |
| ACYCLOVIR SODIUM | DR REDDYS | ANDA 207919 | — | Jun 17, 2020 | |
| ACYCLOVIR SODIUM | ZYDUS PHARMS | ANDA 206535 | AP | Aug 31, 2018 | |
| ACYCLOVIR SODIUM×2 | ZYDUS PHARMS | ANDA 206606 | — | Jun 13, 2017 | |
| ACYCLOVIR SODIUM×2 | PHARMOBEDIENT | ANDA 203927 | — | Mar 29, 2017 | |
| ACYCLOVIR SODIUM×2 | HIKMA | ANDA 205771 | — | Feb 29, 2016 | |
| ACYCLOVIR SODIUM | EUGIA PHARMA | ANDA 203701 | AP | Oct 11, 2013 | |
| ACYCLOVIR SODIUM | TEVA PARENTERAL | ANDA 075627 | — | Mar 28, 2001 | |
| ACYCLOVIR | ABBVIE | ANDA 075114 | — | Jul 26, 1999 | |
| ACYCLOVIR SODIUM | HOSPIRA | ANDA 075065 | — | Feb 25, 1999 | |
| ACYCLOVIR SODIUM | FRESENIUS KABI USA | ANDA 074930 | AP | May 13, 1998 | |
| ACYCLOVIR SODIUM | FRESENIUS KABI USA | ANDA 075015 | — | Apr 30, 1998 | |
| ACYCLOVIR SODIUM×2 | APOTHECON | ANDA 074897 | — | Feb 27, 1998 | |
| ACYCLOVIR IN SODIUM CHLORIDE 0.9% PRESERVATIVE FREE×2 | EUROHLTH INTL SARL | ANDA 074885 | — | Dec 19, 1997 | |
| ACYCLOVIR SODIUM×2 | EUROHLTH INTL SARL | ANDA 074913 | — | Oct 15, 1997 | |
| ACYCLOVIR SODIUM×2 | TEVA PARENTERAL | ANDA 074969 | — | Aug 26, 1997 | |
| ACYCLOVIR SODIUM×2 | CHARTWELL INJECTABLE | ANDA 074596 | — | Apr 22, 1997 | |
| ACYCLOVIR SODIUM×2 | HOSPIRA | ANDA 074663 | — | Apr 22, 1997 | |
| ACYCLOVIR SODIUM×2 | HOSPIRA | ANDA 074758 | — | Apr 22, 1997 | |
| ACYCLOVIR SODIUM | HOSPIRA | ANDA 074720 | — | Apr 22, 1997 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Acyclovir sodium — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
