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I just saw this. FDA rejects Endo's deadline. Generic Opana will be produced but could change again in May 2013 The Pink Sheet Daily: FDA Rejects Endo’s Deadline On Opana ER Petition; Impax Product May Become New RLD By Brenda Sandburg / “The Pink Sheet†DAILY Dec. 3, 2012 Article # 14121203008 Executive Summary Endo files suit against FDA seeking preliminary injunction to require FDA to say whether Endo’s withdrawal of non-crush resistant Opana ER was for safety reasons; FDA contends it has until May 10, 2013 to make this decision. ## To be completely honest, by the time any of it gets produced, approved and is ready to hit shelves, we could be into May 2013 and it may not help anyone, after all. Learn more Opana d...

7 REPLIES Filed under Opana
NDC 0113-1412 NDC Database

Good Sense Naproxen Sodium 220 mg Oral Tablet, Film Coated by L. Perrigo Company ## Package Codes: 0113-1412-71 ## Active Ingredients: Naproxen Sodium

NDC 0220-1412 NDC Database

Cocculus Indicus 6 [Hp_c]/6[hp_c] Oral Pellet by Boiron ## Package Codes: 0220-1412-41

NDC 0268-1412 NDC Database

Ligustrum Vulgare Pollen .1 g/ml Subcutaneous Injection, Solution by Alk-abello, Inc. ## Package Codes: 0268-1412-10, 0268-1412-50

NDC 0270-1412 NDC Database

Isovue-m 612 mg/ml Intrathecal Injection, Solution by Bracco Diagnostics Inc ## Package Codes: 0270-1412-15

NDC 0407-1412 NDC Database

Omnipaque 518 mg/ml Intrathecal; Intravascular; Intravenous; Oral Injection by Ge Healthcare Inc. ## Package Codes: 0407-1412-10, 0407-1412-20, 0407-1412-27, 0407-1412-28, 0407-1412-29, 0407-1412-30, 0407-1412-33, 0407-1412-34, 0407-1412-35, 0407-1412-38, 0407-1412-39, 0407-1412-40, 0407-1412-49, 0407-1412-50, 0407-1412-60, 0407-1412-84 ## Active Ingredients: Iohexol

NDC 0409-1412 NDC Database

Bumetanide .25 mg/ml Intramuscular; Intravenous Injection, Solution by Hospira, Inc. ## Package Codes: 0409-1412-04, 0409-1412-10, 0409-1412-49, 0409-1412-50

NDC 10742-1412 NDC Database

Phisoderm Clear Confidence Daily Gel Face Wash 20 mg/ml Topical Liquid by The Mentholatum Company ## Package Codes: 10742-1412-1

NDC 22840-1412 NDC Database

White Alder Pollen .001 g/ml Intradermal; Percutaneous; Subcutaneous Solution by Greer Laboratories, Inc. ## Package Codes: 22840-1412-1

NDC 33992-1412 NDC Database

Instant Hand Sanitizer With Moisturizers (Aloe Vera and Moisturizers) 62 ml/100ml Topical Gel by Greenbrier International ## Package Codes: 33992-1412-1

NDC 36987-1412 NDC Database

Broccoli .1 g/ml Intradermal; Subcutaneous Injection, Solution by Nelco Laboratories, Inc. ## Package Codes: 36987-1412-1, 36987-1412-2, 36987-1412-3, 36987-1412-4

NDC 43742-1412 NDC Database

Mycocombo Oral Liquid by Deseret Biologicals, Inc. ## Package Codes: 43742-1412-1

NDC 50090-1412 NDC Database

Valsartan and Hydrochlorothiazide Oral Tablet, Film Coated by A-s Medication Solutions ## Markings: I;62 ## Shape: Oval ## Color: Red ## Package Codes: 50090-1412-0, 50090-1412-1

NDC 51662-1412 NDC Database

Lidocaine Hci and Epinephrine With Epinephrine Epidural; Infiltration; Intracaudal; Perineural Injection, Solution by Hf Acquisition Co LLC, Dba Healthfirst ## Package Codes: 51662-1412-1 ## Active Ingredients: Epinephrine Bitartrate + Lidocaine Hydrochloride Anhydrous

NDC 55154-1412 NDC Database

Risperidone 0.5 mg Oral Tablet by Cardinal Health ## Markings: Ris;0;5;PATR ## Shape: Oval ## Color: Brown ## Package Codes: 55154-1412-0, 55154-1412-9

NDC 59762-1412 NDC Database

Mirtazapine 30 mg Disintegrating Tablet by Greenstone LLC ## Markings: 37;A ## Shape: Round ## Color: White ## Package Codes: 59762-1412-7

NDC 61957-1412 NDC Database

Capture Totale Radiance Restoring Serum Foundation Spf 15 012 Topical Liquid by Parfums Christian Dior ## Package Codes: 61957-1412-1

NDC 63479-1412 NDC Database

N12 Sublingual Solution/ Drops by Apex Energetics Inc. ## Package Codes: 63479-1412-1

NDC 64942-1412 NDC Database

Dove 20.2 g/100g Topical Aerosol, Spray by Conopco Inc. D/B/A Unilever ## Package Codes: 64942-1412-1

NDC 67296-1412 NDC Database

Ketorolac Tromethamine 10 mg Oral Tablet, Film Coated by Redpharm Drug, Inc. ## Package Codes: 67296-1412-1, 67296-1412-2

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