Trimipramine Oral Capsule
- Brand(s)
- Surmontil
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Teva Women'S Health, Inc. (2015-02-09)
- Oldest Current Product
- 1990-09-30
- License(s)
- NDA, ANDA
- RxNORM
- ORAL CAPSULE\TRIMIPRAMINE
- FDAOB
- ORAL\CAPSULE\TRIMIPRAMINE MALEATE
- SPL Active
- ORAL\CAPSULE\TRIMIPRAMINE MALEATE
- SPL Moiety
- ORAL\CAPSULE\TRIMIPRAMINE
product(s) by strength(s)
trimipramine 100 mg oral capsule
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 512850554 | Surmontil | NDA | Teva Women'S Health, Inc. | 1990-09-30 | TRIMIPRAMINE MALEATE | ORAL | CAPSULE | NDA016792 | 0177d783-773c-41bf-9db9-eb7e5c64474a |
generic product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 459630295 | ANDA | Actavis Inc. | 2011-10-21 | TRIMIPRAMINE MALEATE | ORAL | CAPSULE | ANDA077361 | 3e1e4157-bc15-4e2a-bb2a-ff41b2a8f905 |
trimipramine 25 mg oral capsule
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 512850538 | Surmontil | NDA | Teva Women'S Health, Inc. | 1990-09-30 | TRIMIPRAMINE MALEATE | ORAL | CAPSULE | NDA016792 | 0177d783-773c-41bf-9db9-eb7e5c64474a |
generic product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 459630293 | ANDA | Actavis Inc. | 2011-11-21 | TRIMIPRAMINE MALEATE | ORAL | CAPSULE | ANDA077361 | 3e1e4157-bc15-4e2a-bb2a-ff41b2a8f905 |
trimipramine 50 mg oral capsule
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 512850539 | Surmontil | NDA | Teva Women'S Health, Inc. | 1990-09-30 | TRIMIPRAMINE MALEATE | ORAL | CAPSULE | NDA016792 | 0177d783-773c-41bf-9db9-eb7e5c64474a |
generic product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 459630294 | ANDA | Actavis Inc. | 2011-11-21 | TRIMIPRAMINE MALEATE | ORAL | CAPSULE | ANDA077361 | 3e1e4157-bc15-4e2a-bb2a-ff41b2a8f905 |
application(s)
| # | id | title | deprecated | applicant | approved | approved drug |
|---|---|---|---|---|---|---|
| 1 | ANDA071283 | TRIMIPRAMINE MALEATE | True | USL PHARMA INC | 1987-12-08 | ANDA071283_001 |
| 2 | ANDA071284 | TRIMIPRAMINE MALEATE | True | USL PHARMA INC | 1987-12-08 | ANDA071284_001 |
| 3 | ANDA071285 | TRIMIPRAMINE MALEATE | True | USL PHARMA INC | 1987-12-08 | ANDA071285_001 |
| 4 | ANDA077361 | TRIMIPRAMINE MALEATE | MIKAH PHARMA LLC | 2006-08-02 | ANDA077361_001, ANDA077361_002, ANDA077361_003 | |
| 5 | NDA016792 | SURMONTIL | ODYSSEY PHARMACEUTICALS INC | NDA016792_001, NDA016792_002, NDA016792_003 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | route | dose form | rld | TE | approved | application |
|---|---|---|---|---|---|---|---|---|---|
| 1 | ANDA071283_001 | discontinued | TRIMIPRAMINE MALEATE (EQ 25MG BASE) | ORAL | CAPSULE | False | 1987-12-08 | TRIMIPRAMINE MALEATE | |
| 2 | ANDA071284_001 | discontinued | TRIMIPRAMINE MALEATE (EQ 50MG BASE) | ORAL | CAPSULE | False | 1987-12-08 | TRIMIPRAMINE MALEATE | |
| 3 | ANDA071285_001 | discontinued | TRIMIPRAMINE MALEATE (EQ 100MG BASE) | ORAL | CAPSULE | False | 1987-12-08 | TRIMIPRAMINE MALEATE | |
| 4 | ANDA077361_001 | RX | TRIMIPRAMINE MALEATE (EQ 25MG BASE) | ORAL | CAPSULE | False | AB | 2006-08-02 | TRIMIPRAMINE MALEATE |
| 5 | ANDA077361_002 | RX | TRIMIPRAMINE MALEATE (EQ 50MG BASE) | ORAL | CAPSULE | False | AB | 2006-08-02 | TRIMIPRAMINE MALEATE |
| 6 | ANDA077361_003 | RX | TRIMIPRAMINE MALEATE (EQ 100MG BASE) | ORAL | CAPSULE | False | AB | 2006-08-02 | TRIMIPRAMINE MALEATE |
| 7 | NDA016792_001 | RX | TRIMIPRAMINE MALEATE (EQ 25MG BASE) | ORAL | CAPSULE | False | AB | SURMONTIL | |
| 8 | NDA016792_002 | RX | TRIMIPRAMINE MALEATE (EQ 50MG BASE) | ORAL | CAPSULE | True | AB | SURMONTIL | |
| 9 | NDA016792_003 | RX | TRIMIPRAMINE MALEATE (EQ 100MG BASE) | ORAL | CAPSULE | False | AB | 1982-09-15 | SURMONTIL |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 0177d783-773c-41bf-9db9-eb7e5c64474a (view SPL) | SURMONTIL (Trimipramine Maleate) Rx only | prescription | Human Prescription | Teva Women'S Health, Inc. | 2015-02-09 | 5 | 512850538, 512850539, 512850554 | |
| 2 | 3e1e4157-bc15-4e2a-bb2a-ff41b2a8f905 (view SPL) | TRIMIPRAMINE MALEATE CAPSULES, 25 MG, 50 MG and 100 MG Rx Only | prescription | Human Prescription | Actavis Inc. | MANUFACTURE | 2015-05-19 | 6 | 459630293, 459630294, 459630295 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII