FDA Orange Book · active-ingredient family
Maprotiline hydrochloride
Maprotiline hydrochloride is approved as 1 brand and 10 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:LUDIOMIL · NDA 017543
1
Brand (NDA)
10
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| LUDIOMIL×3 | NOVARTIS | NDA 017543 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (10)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| MAPROTILINE HYDROCHLORIDE×3 | RISING | ANDA 072285 | — | Oct 03, 1988 | |
| MAPROTILINE HYDROCHLORIDE | HERITAGE PHARMA | ANDA 072162 | — | Jun 01, 1988 | |
| MAPROTILINE HYDROCHLORIDE | HERITAGE PHARMA | ANDA 072163 | — | Jun 01, 1988 | |
| MAPROTILINE HYDROCHLORIDE | WATSON LABS | ANDA 072164 | — | Jun 01, 1988 | |
| MAPROTILINE HYDROCHLORIDE | AM THERAP | ANDA 072129 | — | Jan 14, 1988 | |
| MAPROTILINE HYDROCHLORIDE | AM THERAP | ANDA 072130 | — | Jan 14, 1988 | |
| MAPROTILINE HYDROCHLORIDE | AM THERAP | ANDA 072131 | — | Jan 14, 1988 | |
| MAPROTILINE HYDROCHLORIDE | WATSON LABS | ANDA 071943 | — | Dec 30, 1987 | |
| MAPROTILINE HYDROCHLORIDE | WATSON LABS | ANDA 071944 | — | Dec 30, 1987 | |
| MAPROTILINE HYDROCHLORIDE | WATSON LABS | ANDA 071945 | — | Dec 30, 1987 |
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.
Maprotiline hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
