Diclofenac Oral Capsule
- Brand(s)
- Zipsor, Zorvolex
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Depomed, Inc. (2015-09-01)
- Oldest Current Product
- 2009-06-16
- License(s)
- NDA
- RxNORM
- ORAL CAPSULE\DICLOFENAC
- FDAOB
- ORAL\CAPSULE\DICLOFENAC
ORAL\CAPSULE\DICLOFENAC POTASSIUM - SPL Active
- ORAL\CAPSULE, LIQUID FILLED\DICLOFENAC POTASSIUM
ORAL\CAPSULE\DICLOFENAC - SPL Moiety
- ORAL\CAPSULE, LIQUID FILLED\DICLOFENAC
ORAL\CAPSULE\DICLOFENAC
product(s) by strength(s)
diclofenac 18 mg oral capsule
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 422110203 | Zorvolex | NDA | Iroko Pharmaceuticals, Llc | 2013-10-31 | DICLOFENAC | ORAL | CAPSULE | NDA204592 | dff10e66-a577-451d-ba75-1889458ca833 |
diclofenac 35 mg oral capsule
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 422110204 | Zorvolex | NDA | Iroko Pharmaceuticals, Llc | 2013-10-31 | DICLOFENAC | ORAL | CAPSULE | NDA204592 | dff10e66-a577-451d-ba75-1889458ca833 |
diclofenac potassium 25 mg oral capsule
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 139130008 | Zipsor | NDA | Depomed, Inc. | 2009-06-16 | DICLOFENAC POTASSIUM | ORAL | CAPSULE, LIQUID FILLED | NDA022202 | c982eca0-fc41-11e1-a9c8-0002a5d5c51b |
relabeler product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | equivalent product | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 353560537 | Zipsor | NDA | Lake Erie Medical Dba Quality Care Products Llc | 2010-12-22 | DICLOFENAC POTASSIUM | ORAL | CAPSULE, LIQUID FILLED | 664790592 | NDA022202 | 61420046-b04b-4532-a21d-65986966f681 |
| 2 | 430630205 | Zipsor | NDA | Pd-Rx Pharmaceuticals, Inc. | 2010-04-30 | DICLOFENAC POTASSIUM | ORAL | CAPSULE, LIQUID FILLED | 664790592 | NDA022202 | b20c6938-cf96-4175-9eb3-d6ae3a43059c |
application(s)
| # | id | title | applicant | approved | patent | exclusivity | approved drug |
|---|---|---|---|---|---|---|---|
| 1 | NDA022202 | ZIPSOR | DEPOMED INC | 2009-06-16 | p6287594, SUBSTANCE p7884095, NONSTEROIDAL ANTI-INFLAMMATORY DRUG INDICATED FOR RELIEF OF MILD TO MODERATE ACUTE PAIN p7662858, NONSTEROIDAL ANTI-INFLAMMATORY DRUG INDICATED FOR RELIEF OF MILD TO MODERATE ACUTE PAIN p8623920, DICLOFENAC POTASSIUM FOR RELIEF OF MILD TO MODERATE ACUTE PAIN p8110606, NONSTEROIDAL ANTI-INFLAMMATORY DRUG INDICATED FOR RELIEF OF MILD TO MODERATE ACUTE PAIN p6365180, NONSTEROIDAL ANTI-INFLAMMATORY DRUG INDICATED FOR RELIEF OF MILD TO MODERATE ACUTE PAIN, SUBSTANCE p7939518, NONSTEROIDAL ANTI-INFLAMMATORY DRUG INDICATED FOR RELIEF OF MILD TO MODERATE ACUTE PAIN | NDA022202_001 | |
| 2 | NDA204592 | ZORVOLEX | IROKO PHARMACEUTICALS LLC | 2013-10-18 | p9173854, SUBSTANCE p9180096, SUBSTANCE p8999387, TREATMENT OF PAIN p9017721, SUBSTANCE p8679544, SUBSTANCE | INDICATED FOR MANAGEMENT OF OSTEOARTHRITIS PAIN. [2017-08-22] NEW PRODUCT [2016-10-18] | NDA204592_001, NDA204592_002 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | route | dose form | rld | approved | application |
|---|---|---|---|---|---|---|---|---|
| 1 | NDA022202_001 | RX | DICLOFENAC POTASSIUM (25MG) | ORAL | CAPSULE | True | 2009-06-16 | ZIPSOR |
| 2 | NDA204592_001 | RX | DICLOFENAC (18MG) | ORAL | CAPSULE | False | 2013-10-18 | ZORVOLEX |
| 3 | NDA204592_002 | RX | DICLOFENAC (35MG) | ORAL | CAPSULE | True | 2013-10-18 | ZORVOLEX |
patent(s)
| # | id | expiration date | application(s) |
|---|---|---|---|
| 1 | p6287594 (view patent) | 2019-01-15 | NDA022202 |
| 2 | p6365180 (view patent) | 2019-07-15 | NDA022202 |
| 3 | p7662858 (view patent) | 2029-02-24 | NDA022202 |
| 4 | p7884095 (view patent) | 2029-02-24 | NDA022202 |
| 5 | p7939518 (view patent) | 2029-02-24 | NDA022202 |
| 6 | p8110606 (view patent) | 2029-02-24 | NDA022202 |
| 7 | p8623920 (view patent) | 2029-02-24 | NDA022202 |
| 8 | p8679544 (view patent) | 2030-04-23 | NDA204592 |
| 9 | p8999387 (view patent) | 2030-04-23 | NDA204592 |
| 10 | p9017721 (view patent) | 2030-04-23 | NDA204592 |
| 11 | p9173854 (view patent) | 2030-04-23 | NDA204592 |
| 12 | p9180096 (view patent) | 2030-04-23 | NDA204592 |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 61420046-b04b-4532-a21d-65986966f681 (view SPL) | These highlights do not include all the information needed to use Zipsor safely and effectively. See full prescribing information for Zipsor. Zipsor (diclofenac potassium) Liquid Filled CapsuleInitial U.S. Approval: [1988] | prescription | Human Prescription | Lake Erie Medical Dba Quality Care Products Llc | MANUFACTURE, repack | 2010-12-22 | 2043 | 353560537 |
| 2 | b20c6938-cf96-4175-9eb3-d6ae3a43059c (view SPL) | These highlights do not include all the information needed to use Zipsor safely and effectively. See full prescribing information for Zipsor. Zipsor (diclofenac potassium) Liquid Filled CapsuleInitial U.S. Approval: [1988] | prescription | Human Prescription | Pd-Rx Pharmaceuticals, Inc. | repack | 2009-06-05 | 6 | 430630205 |
| 3 | c982eca0-fc41-11e1-a9c8-0002a5d5c51b (view SPL) | These highlights do not include all the information needed to use Zipsor safely and effectively. See full prescribing information for Zipsor. Zipsor (diclofenac potassium) Liquid Filled CapsuleInitial U.S. Approval: [1988] | prescription | Human Prescription | Depomed, Inc. | LABEL, MANUFACTURE, PACK | 2015-09-01 | 7 | 139130008 |
| 4 | dff10e66-a577-451d-ba75-1889458ca833 (view SPL) | These highlights do not include all the information needed to use ZORVOLEX safely and effectively. See full prescribing information for ZORVOLEX. ZORVOLEX (diclofenac) capsules, for oral useInitial U.S. Approval: 1988 | prescription | Human Prescription | Iroko Pharmaceuticals, Llc | manufacture | 2014-08-29 | 4 | 422110203, 422110204 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII