DICLOFENAC SODIUM; MISOPROSTOL | A201089 | ACTAVIS LABORATORIES FL INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
King and Spalding LLP - Citizen Petition FDA-2007-P-0348 · 7 docket documents King & Spalding LLP filed a suitability petition under Section 505(j)(2)(C) requesting that the FDA declare a new enteric-coated capsule dosage form containing diclofenac sodium and misoprostol in 50 mg/200 mcg and 75 mg/200 mcg combinations suitable for submission via ANDA, with the reference liste | Other | 2008-05-23 | Granted | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$1.00
per ea
Lowest NADAC/Unit
$0.8822
per ea
Brand NDCs
0
Generic NDCs
5
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00591039860DICLOFENAC-MISOPROSTOL DR 75-0.2 MG TABLET | $1.00 | EA | Generic | — | 2026-06-17 |
| 68001023206DICLOFENAC-MISOPROSTOL DR 75-0.2 MG TABLET | $1.00 | EA | Generic | — | 2026-06-17 |
| 00591039719DICLOFENAC-MISOPROSTOL DR 50-0.2 MG TABLET | $0.8822 | EA | Generic | — | 2026-06-17 |
| 00591039760DICLOFENAC-MISOPROSTOL DR 50-0.2 MG TABLET | $0.8822 | EA | Generic | — | 2026-06-17 |
| 68001023106DICLOFENAC-MISOPROSTOL DR 50-0.2 MG TABLET | $0.8822 | EA | Generic | — | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.