FDA Orange Book · active-ingredient family
Ampicillin sodium
Ampicillin sodium is approved as 2 brand and 29 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:PENBRITIN-S · NDA 050072
2
Brand (NDA)
29
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable, powder
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PENBRITIN-SRLD×6 | WYETH AYERST | NDA 050072 | — | Approved Prior to Jan 1, 1982 | |
| POLYCILLIN-N×5 | BRISTOL | NDA 050309 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (29)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| AMPICILLIN SODIUM×5 | SAGENT PHARMS INC | ANDA 090583 | AP | Nov 27, 2015 | |
| AMPICILLIN SODIUM | SAGENT PHARMS INC | ANDA 090581 | AP | Oct 20, 2015 | |
| AMPICILLIN SODIUM×4 | HOSPIRA | ANDA 202864 | — | Sep 04, 2015 | |
| AMPICILLIN SODIUM | HOSPIRA | ANDA 202865 | — | Sep 04, 2015 | |
| AMPICILLIN SODIUM×4 | ONESOURCE SPECIALTY | ANDA 201025 | AP | Apr 09, 2014 | |
| AMPICILLIN SODIUM | ONESOURCE SPECIALTY | ANDA 202198 | AP | Apr 07, 2014 | |
| AMPICILLIN SODIUM | ISTITUTO BIO ITA SPA | ANDA 201404 | AP | Dec 20, 2013 | |
| AMPICILLIN SODIUM×3 | ACS DOBFAR SPA | ANDA 090884 | — | Apr 03, 2013 | |
| AMPICILLIN SODIUM | ACS DOBFAR SPA | ANDA 090889 | AP | Apr 03, 2013 | |
| AMPICILLIN SODIUM×5 | EUGIA PHARMA SPECLTS | ANDA 065499 | AP | Aug 17, 2010 | |
| AMPICILLIN SODIUM | EUGIA PHARMA SPECLTS | ANDA 065493 | AP | Aug 17, 2010 | |
| AMPICILLIN SODIUM×4 | ANTIBIOTICE | ANDA 090354 | AP | Dec 28, 2009 | |
| AMPICILLIN SODIUM×2 | ISTITUTO BIO ITA SPA | ANDA 062797 | AP | Jul 12, 1993 | |
| AMPICILLIN SODIUM×8 | HQ SPECLT PHARMA | ANDA 062772 | AP | Apr 15, 1993 | |
| AMPICILLIN SODIUM | HQ SPECLT PHARMA | ANDA 063142 | AP | Apr 15, 1993 | |
| AMPICILLIN SODIUM×5 | WATSON LABS INC | ANDA 062816 | — | Oct 24, 1988 | |
| AMPICILLIN SODIUM | WATSON LABS INC | ANDA 062994 | — | Sep 15, 1988 | |
| AMPICILLIN SODIUM×5 | APOTHECON | ANDA 062860 | — | Feb 05, 1988 | |
| AMPICILLIN SODIUM×3 | ISTITUTO BIO ITA SPA | ANDA 062719 | AP | May 12, 1987 | |
| AMPICILLIN SODIUM×2 | SANDOZ | ANDA 062738 | — | Feb 19, 1987 | |
| AMPICILLIN SODIUM×2 | INTL MEDICATION | ANDA 062634 | — | Jan 09, 1987 | |
| TOTACILLIN-N×2 | GLAXOSMITHKLINE | ANDA 062727 | — | Dec 19, 1986 | |
| OMNIPEN-N×5 | WYETH AYERST | ANDA 062718 | — | Dec 16, 1986 | |
| AMPICILLIN SODIUM×6 | HIKMA | ANDA 062692 | — | Jun 24, 1986 | |
| AMPICILLIN SODIUM×3 | LILLY | ANDA 062565 | — | Apr 04, 1985 | |
| AMPICILLIN SODIUM×5 | CONSOLIDATED PHARM | ANDA 061936 | — | Approved Prior to Jan 1, 1982 | |
| AMPICILLIN SODIUM×6 | SANDOZ | ANDA 061395 | AP | Approved Prior to Jan 1, 1982 | |
| OMNIPEN-N×5 | WYETH AYERST | ANDA 060626 | — | Approved Prior to Jan 1, 1982 | |
| TOTACILLIN-N×6 | GLAXOSMITHKLINE | ANDA 060677 | — | Approved Prior to Jan 1, 1982 |
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.
Ampicillin sodium — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
