DICLOFENAC SODIUM; MISOPROSTOL | A200540 | EXELA HOLDINGS 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.
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