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Pharmaceuticals policy / Ethers / Drug safety / Pharmaceutical industry / Janssen Pharmaceutica / Perrigo / Food and Drug Administration / Over-the-counter drug / Abbreviated New Drug Application / Pharmacology / Pharmaceutical sciences / Medicine


September 19,200l Docket No. 98N-0337 Food and Drug Administration
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Document Date: 2001-10-29 14:36:06

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File Size: 571,32 KB

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City

Rockville / /

Company

Perrigo Company / L. PERRIGO COMPANY Brian Schuster / Certain Petitions Perrigo Company / /

Event

FDA Phase / Product Recall / Product Issues / Person Communication and Meetings / /

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IndustryTerm

drug product / retail / telephone conversation / particular product / /

Organization

Division of OTC Drug Products John Grace OGD Labeling Review Branch / office of OTC Drug Products / Food and Drug Administration / office of Generic Drugs / Division of OTC Drugs / /

Person

Gary Buehler / Gerald Rachanow / Brian Schuster / Charles Ganley / John Grace / /

/

Position

Director / Regulatory Affairs Manager / Regulatory Counsel / Manager / ANDA Submissions / /

Product

Miconazole Nitrate / APP23 Tablets / Loperamide Hydrochloride / APP21 Tablets / petitions / Tablets Tablets / Clemastine Fumarate / Minoxidil / APP24 Tablets / Doxylamine Succinate / Cimetidine / Pseudoephedrine Hydrochloride / APP19 Doxylamine Succinate Tablets / CBE supplement / APP25 / Hydrochloride / Cimetidine Tablets / for / Clemastine Fumarate Tablets USP / Pseudoephedrine Hydrochloride Extended Release / changes / Listed Drug / OTC drug / /

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