DIPHENHYDRAMINE HYDROCHLORIDE | A071292 | L PERRIGO CO
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
FDA/CDER to Buchanan Ingersoll & Rooney PC - Petition Denial FDA-2009-P-0589 Buchanan Ingersoll & Rooney PC filed a citizen petition requesting that FDA confirm dihydrocodeine bitartrate as generally recognized as safe and effective (GRAS/E) when used at doses not exceeding 10 milligrams per dose in prescription liquid antitussive products, both as a sole active ingredient a | Other | 2012-03-09 | Denied | — |
Buchanan Ingersoll & Rooney PC - Citizen Petition FDA-2009-P-0589 Buchanan Ingersoll & Rooney PC filed this citizen petition on December 1, 2009, requesting that the FDA Commissioner confirm dihydrocodeine bitartrate as Generally Recognized as Safe and Effective (GRAS/E) for use as an antitussive in prescription liquid cough/cold drug products at doses not exceedi | Other | 2009-12-16 | Denied | — |
Citizen Petition from Baltimore City Health Department et al FDA-2007-P-0050 The Baltimore City Health Department and other undersigned petitioners submitted this citizen petition under 21 CFR Section 10.30 requesting that the FDA provide a public statement that over-the-counter antitussive, expectorant, nasal decongestant, antihistamine, and combination cough and cold produ | Other | 2008-06-26 | Open | Baltimore City Health Department et al |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.