DICYCLOMINE HYDROCHLORIDE | A085082 | WATSON LABORATORIES INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Aurobindo Pharma USA Inc FDA-2018-P-1869 Aurobindo Pharma USA Inc. filed this citizen petition under Section 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA designate the approved generic product Dicyclomine Hydrochloride Capsules USP, 10 mg (ANDA #085082) of Watson Laboratories Inc. as an alternative reference s | 505(q) | 2018-05-14 | Denied | Aurobindo Pharma USA Inc |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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