Zorvolex is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Iroko Pharmaceuticals Llc. The primary component is Diclofenac.
Product ID | 42211-203_73b05aef-df1b-4b6c-8409-021f697deae1 |
NDC | 42211-203 |
Product Type | Human Prescription Drug |
Proprietary Name | Zorvolex |
Generic Name | Diclofenac |
Dosage Form | Capsule |
Route of Administration | ORAL |
Marketing Start Date | 2013-10-31 |
Marketing Category | NDA / NDA |
Application Number | NDA204592 |
Labeler Name | Iroko Pharmaceuticals LLC |
Substance Name | DICLOFENAC |
Active Ingredient Strength | 18 mg/1 |
Pharm Classes | Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC] |
NDC Exclude Flag | N |
Listing Certified Through | 2020-12-31 |
Marketing Start Date | 2013-10-31 |
NDC Exclude Flag | N |
Sample Package? | N |
Marketing Category | NDA |
Application Number | NDA204592 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | EA |
Marketing Start Date | 2013-10-31 |
Marketing Category | NDA |
Application Number | NDA204592 |
Product Type | HUMAN PRESCRIPTION DRUG |
Marketing Start Date | 2013-10-31 |
Marketing Category | NDA |
Application Number | NDA204592 |
Product Type | HUMAN PRESCRIPTION DRUG |
Marketing Start Date | 2013-10-31 |
Marketing Category | NDA |
Application Number | NDA204592 |
Product Type | HUMAN PRESCRIPTION DRUG |
Marketing Start Date | 2013-10-31 |
Marketing End Date | 2013-12-17 |
Ingredient | Strength |
---|---|
DICLOFENAC | 18 mg/1 |
NDC | Brand Name | Generic Name |
---|---|---|
42211-203 | Zorvolex | diclofenac |
42211-204 | Zorvolex | diclofenac |
69344-204 | Zorvolex | Zorvolex |
69344-203 | Zorvolex | Zorvolex |
0378-8750 | Diclofenac Sodium | diclofenac |
17856-0833 | Diclofenac sodium | Diclofenac |
42291-256 | Diclofenac sodium | Diclofenac |
45865-986 | Diclofenac Sodium | Diclofenac |
46122-711 | Diclofenac Sodium | Diclofenac |
50090-2787 | Diclofenac sodium | Diclofenac |
50090-3316 | Diclofenac Sodium | Diclofenac |
50090-4621 | Diclofenac sodium | Diclofenac |
50268-237 | Diclofenac sodium | Diclofenac |
50436-0833 | Diclofenac sodium | Diclofenac |
53149-4902 | Diclofenac Sodium | Diclofenac |
55700-675 | Diclofenac sodium | Diclofenac |
55700-735 | Diclofenac Sodium | Diclofenac |
57896-142 | Diclofenac Sodium | Diclofenac |
58602-601 | Diclofenac Sodium | Diclofenac |
58602-602 | Diclofenac Sodium | Diclofenac |
58602-603 | Diclofenac Sodium | Diclofenac |
63187-762 | Diclofenac sodium | Diclofenac |
65162-683 | Diclofenac Sodium | Diclofenac |
65162-833 | Diclofenac sodium | Diclofenac |
65162-911 | Diclofenac Sodium | Diclofenac |
68071-3159 | Diclofenac sodium | Diclofenac |
68071-4246 | Diclofenac sodium | Diclofenac |
68788-6831 | Diclofenac sodium | Diclofenac |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ZORVOLEX 85413540 4505759 Live/Registered |
ZYLA LIFE SCIENCES US INC. 2011-09-01 |