FDA Orange Book · active-ingredient family
Metoprolol tartrate
Metoprolol tartrate is approved as 4 brand and 33 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:LOPRESSOR · NDA 218698
4
Brand (NDA)
33
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable, solution, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| LOPRESSORRLD | XTM CONSULTING | NDA 218698 | — | Aug 28, 2025 | |
| LOPRESSORRLD | RUBICON RESEARCH | NDA 219373 | — | Apr 10, 2025 | |
| LOPRESSORRLD | NOVARTIS | NDA 018704 | — | Mar 30, 1984 | |
| LOPRESSORRLD×2 | VALIDUS PHARMS | NDA 017963 | AB | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (33)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| METOPROLOL TARTRATE×3 | ZYDUS PHARMS | ANDA 212402 | — | Apr 19, 2023 | |
| METOPROLOL TARTRATE×3 | SCIEGEN PHARMS | ANDA 208955 | AB | Feb 05, 2020 | |
| METOPROLOL TARTRATE×5 | RUBICON RESEARCH | ANDA 200981 | AB | Oct 28, 2014 | |
| METOPROLOL TARTRATE | GLAND | ANDA 204205 | AP | Aug 27, 2014 | |
| METOPROLOL TARTRATE×3 | ALEMBIC PHARMS LTD | ANDA 202871 | AB | May 28, 2013 | |
| METOPROLOL TARTRATE | BAXTER HLTHCARE CORP | ANDA 078950 | AP | Apr 29, 2013 | |
| METOPROLOL TARTRATE | LUITPOLD | ANDA 091307 | — | Dec 29, 2010 | |
| METOPROLOL TARTRATE | FRESENIUS KABI USA | ANDA 091045 | AP | Oct 25, 2010 | |
| METOPROLOL TARTRATE | ONESOURCE SPECIALTY | ANDA 090317 | — | Apr 19, 2010 | |
| METOPROLOL TARTRATE | AM REGENT | ANDA 090386 | — | Sep 30, 2009 | |
| METOPROLOL TARTRATE×3 | SUN PHARM INDUSTRIES | ANDA 073654 | — | Jul 15, 2009 | |
| METOPROLOL TARTRATE×3 | IPCA LABS LTD | ANDA 078459 | AB | Jun 17, 2008 | |
| METOPROLOL TARTRATE | HOSPIRA | ANDA 078085 | AP | Apr 29, 2008 | |
| METOPROLOL TARTRATE | SANDOZ | ANDA 077360 | AP | Oct 02, 2007 | |
| METOPROLOL TARTRATE×5 | AUROBINDO PHARMA | ANDA 077739 | AB | Sep 11, 2007 | |
| METOPROLOL TARTRATE | HIKMA FARMACEUTICA | ANDA 077761 | AP | May 30, 2007 | |
| METOPROLOL TARTRATE×5 | MYLAN | ANDA 076704 | AB | Jan 16, 2004 | |
| METOPROLOL TARTRATE | SUN PHARM INDS INC | ANDA 076670 | — | Jan 15, 2004 | |
| METOPROLOL TARTRATE | HIKMA | ANDA 076495 | AP | Jul 07, 2003 | |
| METOPROLOL TARTRATE | HOSPIRA | ANDA 075160 | — | Jul 06, 1998 | |
| METOPROLOL TARTRATE×2 | SUN PHARM INDS INC | ANDA 074644 | AB | Dec 10, 1996 | |
| METOPROLOL TARTRATE×2 | RENATA | ANDA 074453 | AB | Apr 27, 1995 | |
| METOPROLOL TARTRATE×2 | HERITAGE PHARMA | ANDA 074141 | — | Jan 31, 1995 | |
| METOPROLOL TARTRATE×2 | TEVA | ANDA 074143 | — | Sep 30, 1994 | |
| METOPROLOL TARTRATE×2 | PUREPAC PHARM | ANDA 074380 | — | Jul 29, 1994 | |
| METOPROLOL TARTRATE×2 | WATSON LABS | ANDA 074217 | — | May 27, 1994 | |
| METOPROLOL TARTRATE | CHARTWELL RX | ANDA 073288 | — | Mar 25, 1994 | |
| METOPROLOL TARTRATE | CHARTWELL RX | ANDA 073289 | — | Mar 25, 1994 | |
| METOPROLOL TARTRATE×2 | APOTHECON | ANDA 074258 | — | Jan 27, 1994 | |
| METOPROLOL TARTRATE×2 | TEVA PHARMS | ANDA 074333 | — | Jan 27, 1994 | |
| METOPROLOL TARTRATE | HOSPIRA | ANDA 074133 | — | Dec 21, 1993 | |
| METOPROLOL TARTRATE | WATSON LABS | ANDA 074032 | — | Dec 21, 1993 | |
| METOPROLOL TARTRATE×2 | PHARMOBEDIENT | ANDA 073666 | — | Dec 21, 1993 |
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.
Metoprolol tartrate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
