FDA Orange Book · active-ingredient family
Clomipramine hydrochloride
Clomipramine hydrochloride 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:ANAFRANIL · NDA 019906
1
Brand (NDA)
21
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ANAFRANILRLD×3 | SPECGX LLC | NDA 019906 | AB | Dec 29, 1989 |
Generic (ANDA) products (21)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CLOMIPRAMINE HYDROCHLORIDE×3 | AUROBINDO PHARMA | ANDA 216440 | AB | Mar 20, 2023 | |
| CLOMIPRAMINE HYDROCHLORIDE×3 | ALEMBIC | ANDA 211822 | AB | Aug 04, 2021 | |
| CLOMIPRAMINE HYDROCHLORIDE×3 | AJANTA PHARMA LTD | ANDA 213897 | — | Oct 02, 2020 | |
| CLOMIPRAMINE HYDROCHLORIDE×3 | UNIQUE | ANDA 212285 | AB | Aug 07, 2020 | |
| CLOMIPRAMINE HYDROCHLORIDE×3 | MICRO LABS | ANDA 213219 | AB | Jun 22, 2020 | |
| CLOMIPRAMINE HYDROCHLORIDE×3 | RK PHARMA | ANDA 213221 | — | Jun 22, 2020 | |
| CLOMIPRAMINE HYDROCHLORIDE×3 | TP ANDA HOLDINGS | ANDA 210653 | AB | Apr 03, 2020 | |
| CLOMIPRAMINE HYDROCHLORIDE×3 | IXORA LIFESCIENCE | ANDA 211364 | AB | Feb 07, 2020 | |
| CLOMIPRAMINE HYDROCHLORIDE×3 | JUBILANT CADISTA | ANDA 212218 | AB | Oct 21, 2019 | |
| CLOMIPRAMINE HYDROCHLORIDE×3 | MANKIND PHARMA | ANDA 211767 | AB | Apr 08, 2019 | |
| CLOMIPRAMINE HYDROCHLORIDE×3 | LUPIN | ANDA 209294 | AB | Nov 21, 2018 | |
| CLOMIPRAMINE HYDROCHLORIDE×3 | AMNEAL PHARMS CO | ANDA 208632 | — | Oct 31, 2018 | |
| CLOMIPRAMINE HYDROCHLORIDE×3 | ZYDUS PHARMS | ANDA 208961 | AB | Dec 27, 2017 | |
| CLOMIPRAMINE HYDROCHLORIDE×3 | WATSON LABS | ANDA 074751 | — | Sep 30, 1998 | |
| CLOMIPRAMINE HYDROCHLORIDE×3 | PHARMOBEDIENT | ANDA 074947 | — | Apr 30, 1998 | |
| CLOMIPRAMINE HYDROCHLORIDE×3 | TEVA | ANDA 074958 | — | Aug 26, 1997 | |
| CLOMIPRAMINE HYDROCHLORIDE×3 | SANDOZ | ANDA 074953 | AB | Jun 25, 1997 | |
| CLOMIPRAMINE HYDROCHLORIDE×3 | TEVA | ANDA 074849 | — | Apr 04, 1997 | |
| CLOMIPRAMINE HYDROCHLORIDE×3 | TARO | ANDA 074694 | AB | Dec 31, 1996 | |
| CLOMIPRAMINE HYDROCHLORIDE×3 | WATSON LABS | ANDA 074600 | — | Nov 27, 1996 | |
| CLOMIPRAMINE HYDROCHLORIDE×3 | CHARTWELL RX | ANDA 074364 | AB | Mar 29, 1996 |
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.
Clomipramine hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
