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A prescription for Adderall XR 20 mg was dispensed with Adderall 20 mg. The pharmacist did not realize that an extended release form of Adderall was available. The patient experienced no adverse outcome. Actual Error. Patient received wrong formulation hydrocodone narcotics of Glucophage with wrong directions after refilling of old prescription number when patient had seen physician who ordered the new drug but forgot to mention XR form. Denise Toyer 9/6/02 09:29:57 AM PHARMACfST Jerry Phillips 9/6/02 10:13:15 AM DIRECTOR APPEARS THIS WAY ON ORIGINAL DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION REQUEST FOR CONSULTATION o (Division/Office): ODS Request HFD-400 Parklawn Bldg/Room 15B-03 Attention: Sammie Beam, Project Manager Division of Neuropharmacological Drug Products HFD-120 comments/special instructions: Please find attached the labeling for pending NDA 21-434. The sponsor has chosen to submit a second tradename for consideration. If you should have any questions, please call at: 594-5535 (I am covering for PM Melaine Shin). Thank You Question 1: The sponsor was interested as to whether the proposed scheduled outlined in Amendment, dated 17-JUL-02, would provide sufficient time to conduct a review of the stability data.

FDA response: In this specific case, the answer buy xanax over seas is yes.

Question #2: What will the impact of submitting ; of 40°C/75%RH stability data have on buy oxycodone online the expiry?

FDA response: Expiry will be determined by the amount of stability data submitted and its quality (review issue). Question #3: Is it reasonable buy oxycodone online to expect that with the data submitted, plus the supportive data, a I - ~ expiry would be set? FDA response: Expiry will be determined by the amount of stability data submitted and its quality (review issue). Thomas Oliver 8/8/02 04:56:26 PM CHEMIST APPEARS THIS WAY ON ORIGINAL Food and Drug Administration Rockville, MD 20857 NDA 21-434 high on tramadol Pharmacia & Upjohn Attention: Roma Thomas Regulatory Manager 7000 Portage Road Kalamazoo, Michigan 49001 Dear Ms. Thomas: Please refer to the meeting between representatives of your firm and FDA on May 10, 2002. The purpose of the meeting was to discuss stability data issues concerning pending NDA 21-434. The official minutes of that fleeting are enclosed. You are responsible for notifying us of any significant differences in understanding regarding the meeting outcomes. If you shouldhave any questions, please call Ms.Anna Marie H. Weikel, R.Ph., Regulatory Health Project Manager, at (301) 594-5535. Acting Chemistry Teamleader, Psychiatric Dmgs Division of Neuropharmacological Drug Products Office of New Drug Evaluation I Center for Drug Evaluation and Research The sponsor requested this buy oxycodone online teleconference to seek FDA agreement on the amount and type of stability data that is proposed for this pending NDA in order to obtain a - expiration date for this product.



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