Orange Book FR Safety or Effectiveness Determinations List FDA/CDER

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Specifications	Orange Book FR Safety or Effectiveness Determinations List FDA/CDER
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Approved Drug Products List - Orange Book FR Notice Determination of Safety or Effectiveness List* *See List Footnote January

Specifications	Orange Book FR Safety or Effectiveness Determinations List FDA/CDER
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Content	Approved Drug Products List - Orange Book FR Notice Determination of Safety or Effectiveness List* *See List Footnote January 2012 Page 1 of 24 ACETAMINOPHEN; CODEINE PHOSPHATE TABLET; ORAL ACETAMINOPHEN AND CODEINE PHOSPHATE KV PHARM 325MG;45MG DISC ROXANE 500MG;15MG DISC 500MG;30MG DISC 500MG;60MG DISC N85363001 N89511001 N89512001 N89513001 Feb 26, 1996 May 07, 2002 May 07, 2002 May 07, 2002 Current OB: Current OB: Current OB: Current OB: ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET; ORAL NORCO WATSON LABS 325MG;5MG RX N40099001 Mar 28, 2000 Current OB: ACYCLOVIR TABLET; ORAL ACYCLOVIR TEVA DISC 200MG N74556001 May 21, 1996 Current OB: ALBUTEROL SULFATE SOLUTION; INHALATION PROVENTIL SCHERING DISC DISC VENTOLIN GLAXOSMITHKLINE DISC SYRUP; ORAL PROVENTIL SCHERING DISC EQ 0.083% BASE EQ 0.5% BASE EQ 0.5% BASE EQ 2MG BASE/5ML N19243002 N19243001 N19269002 N18062001 May 23, 2007 May 23, 2007 Apr 04, 2003 Apr 28, 2008 Current OB: Current OB: Current OB: Current OB: AMANTADINE HYDROCHLORIDE TABLET; ORAL SYMMETREL ENDO PHARMS DISC 100MG N18101001 Mar 02, 2011 Current OB: AMILORIDE HYDROCHLORIDE TABLET; ORAL MIDAMOR PADDOCK LLC RX 5MG N18200001 Apr 28, 2008 Current OB: AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE TABLET; ORAL MODURETIC 5-50 MERCK EQ 5MG ANHYDROUS;50MG DISC N18201001 Apr 28, 2008 Current OB: AMIODARONE HYDROCHLORIDE INJECTABLE; INJECTION CORDARONE WYETH PHARMS INC DISC 50MG/ML N20377001 Oct 01, 2008 Current OB: AMOXICILLIN; CLAVULANATE POTASSIUM FOR SUSPENSION; ORAL AUGMENTIN 200 DR REDDYS LABS INC 200MG/5ML;EQ 28.5MG BASE/5ML RX AUGMENTIN 400 DR REDDYS LABS INC 400MG/5ML;EQ 57MG BASE/5ML RX AUGMENTIN ES-600 DR REDDYS LABS INC 600MG/5ML;EQ 42.9MG BASE/5ML RX TABLET, CHEWABLE; ORAL AUGMENTIN 125 DR REDDYS LABS INC 125MG;EQ 31.25MG BASE RX AUGMENTIN 200 DR REDDYS LABS INC 200MG;EQ 28.5MG BASE RX N50725001 N50725002 N50755001 N50597001 N50726001 Dec 07, 2010 Dec 07, 2010 Dec 07, 2010 Dec 07, 2010 Dec 07, 2010 Current OB: Current OB: Current OB: Current OB: Current OB:
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Following Datasheets	UCM123687_1 (2 pages) UCM130716 (4 pages) UCM130717 (4 pages) UCM133432 (2 pages) UCM149971_1 (4 pages) UCM149972_1 (12 pages) UCM149975_1 (125 pages) UCM152828_1 (6 pages) UCM163159_1 (1 pages) UCM163919_1 (1 pages)
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