Re: Roxanol being pulled from the market by FDA
I take that back...it doesn't list oxyfast in the approved or unapproved column
List of Approved Narcotics Drug Products: Morphine Sulfate Tablets and Solutions Drug NDC #* NDA# Manufacturer Morphine Sulfate Tablets 15 & 30 mg 00054 22207 Roxane Morphine Sulfate Oral Solutions
10mg/5 ml &
20mg/5ml 00054
00054 22195 Roxane Morphine Sulfate Extended Release Tablets 00406 76412 Mallinckrodt Morphine Sulfate Tablets Extended Release 60951 75295 Endo/Skyepharma
Hydromorphone Immediate Release Tablets Drug NDC #* NDA# Manufacturer Hydromorphone immediate release tablets – 2, 4, AND 8 mg 00074
00406 19892
78273 Abbott
Mallinckrodt
Oxycodone Drug NDC #* NDA# Manufacturer Oxycodone immediate release tablets – 5, 10, 15, and 30 mg 00406 76758 Mallinckrodt Oxycodone immediate release tablets, 5, 15, and 30 mg 00254 77-712 Vintage Oxycodone Extended Release Tablets, 10 mg 59011 20-553
75923 Purdue
Endo Oxycodone Extended Release Tablets, 15 mg 59011 20553 Purdue Oxycodone Extended Release Tablets, 20 and 40 mg 59011 20553 Purdue * 5-digit Labeler Code of the NDC number
List of Unapproved Narcotics Drug Products Subject to Warning Letters
Firms Products Mallinckrodt Inc. Pharmaceuticals Group Morphine Sulfate Concentrate Oral Solution 20mg/ml Boehringer Ingelheim Roxane Inc. Roxanol Oral Solution, 20 mg/ml;
Roxicodone Tablets, 5 mg Roxane Laboratories, Inc. Hydromorphone Hydrochloride Tablets, 2 mg & 4 mg Glenmark Generics Inc.
Morphine Sulfate Tablets, 15 mg & 30 mg;
Morphine Sulfate Solution Immediate Release Concentrate, 20 mg/ml;
Morphine Sulfate Solution Immediate Release Oral Solution, 20mg/5ml Lannett Company, Inc. Morphine Sulfate Solution Immediate Release 20mg/ml;
Hydromorphone HCl Tablets, 2mg and 4mg Lehigh Valley Technologies Inc. Morphine Sulfate Tablets, 15 mg & 30 mg;
Morphine Sulfate Solution Concentrate, 20 mg/ml Physicians Total Care, Inc. Morphine Sulfate Immediate Release Tablets, 30 mg;
Hydromorphone Tablets, 2 mg;
Hydromorphone Hydrochloride Tablets 4 mg Xanodyne Pharmaceuticals Inc. Roxanol Oral Solution, 20 mg/ml;
Roxicodone Tablets, 5 mg Cody Laboratories, Inc. Morphine Sulfate Solution Immediate Release 20mg/ml * 5-digit Labeler Code of the NDC number
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