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Determination That DEMEROL (Meperidine Hydrochloride) Injectable and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

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Food and Drug Administration, HHS.




The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements. Through this notice, FDA is hoping to stimulate the economy and increase the regulatory certainty with respect to generic versions of these drug products by confirming that generic versions of the subject drug products may continue to be marketed.

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Stacy Kane, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6236, Silver Spring, MD 20993-0002, 301-796-8363,

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In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) (the 1984 amendments), which authorized the approval of duplicate versions of drug products approved under an ANDA procedure. ANDA applicants must, with certain exceptions, show that the drug for which they are seeking approval contains the same active ingredient in the same strength and dosage form as the “listed drug,” which is a version of the drug that was previously approved. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA).

The 1984 amendments include what is now section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the “Approved Drug Products With Therapeutic Equivalence Evaluations,” which is generally known as the “Orange Book.” Under FDA regulations, a drug is removed from the list if the Agency withdraws or suspends approval of the drug's NDA or ANDA for reasons of safety or effectiveness, or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162).

Under § 314.161(a) (21 CFR 314.161(a)), the Agency must determine whether a listed drug was withdrawn from sale for reasons of safety or effectiveness: (1) Before an ANDA that refers to that listed drug may be approved, (2) whenever a listed drug is voluntarily withdrawn from sale and ANDAs that refer to the listed drug have been approved, and (3) when a person petitions for such a determination under 21 CFR 10.25(a) and 10.30. Section 314.161(d) provides that if FDA determines that a listed drug was withdrawn from sale for safety or Start Printed Page 19736effectiveness reasons, the Agency will initiate proceedings that could result in the withdrawal of approval of the ANDAs that refer to the listed drug.

FDA has become aware that the drug products listed in the table in this document are no longer being marketed.

Application No.Drug nameActive ingredient(s)Strength(s)Dosage form/routeApplicant
NDA 005010DEMEROLMeperidine Hydrochloride50 milligrams (mg)/5 milliliter (mL)Syrup; OralU.S. Pharmaceutical Holdings II, LLC.
NDA 006035METHERGINEMethylergonovine Maleate0.2 mgTablet; OralEdison Therapeutics LLC.
NDA 007337PERCODAN and PERCODAN-DEMIAspirin, Oxycodone Hydrochloride, Oxycodone Terephthalate325 mg, 4.5 mg, 0.38 mg; and 325 mg, 2.25 mg, 0.19 mgTablet; OralEndo Pharmaceuticals Inc.
NDA 008720LEVO-DROMORANLevorphanol Tartrate2 mgTablet; OralValeant Pharmaceuticals North America LLC.
NDA 008848PAMINE and PAMINE FORTEMethscopolamine Bromide2.5 mg and 5 mgTablet; OralFougera Pharmaceuticals Inc.
NDA 009470XYLOCAINE VISCOUSLidocaine Hydrochloride2%Solution; OralFresenius Kabi USA, LLC.
NDA 010485ATARAXHydroxyzine Hydrochloride10 mg/5 mLSyrup; OralPfizer Inc.
NDA 010742COMPAZINEProchlorperazine EdisylateEquivalent to (EQ) 5 mg Base/mLInjectable; InjectionGlaxoSmithKline.
NDA 012111MYDRIACYLTropicamide0.5%; 1%Solution/Drops; OphthalmicAlcon Laboratories Inc.
NDA 012248PLEGINEPhendimetrazine Tartrate35 mgTablet; OralWyeth Ayerst Laboratories.
NDA 012365SOMA COMPOUNDAspirin; Carisoprodol325 mg; 200 mgTablet; OralMeda Pharmaceuticals Inc.
NDA 012366SOMA COMPOUND W/CODEINEAspirin; Carisoprodol; Codeine Phosphate325 mg; 200 mg; 16 mgTablet; OralDitto.
NDA 016012VIVACTILProtriptyline Hydrochloride5 mg; 10 mgTablet; OralTeva Women's Health, Inc.
NDA 017352FASTINPhentermine Hydrochloride30 mgCapsule; OralGlaxoSmithKline.
NDA 017690IMODIUMLoperamide Hydrochloride2 mgCapsule; OralJohnson & Johnson Consumer Inc.
NDA 017694IMODIUMLoperamide Hydrochloride2 mgCapsule; OralDitto.
NDA 017741FLORONEDiflorasone Diacetate0.05%Cream; TopicalPharmacia and Upjohn Co.
NDA 017802LO/OVRAL-28Ethinyl Estradiol; Norgestrel0.03 mg; 0.3 mgTablet; Oral-28Wyeth Pharmaceuticals Inc.
NDA 017857STADOLButorphanol Tartrate2 mg/mLInjectable; InjectionDelcor Asset Corporation.
NDA 017857STADOL PRESERVATIVE FREEButorphanol Tartrate1 mg/mL; 2 mg/mLInjectable; InjectionDitto.
NDA 018342WELLCOVORINLeucovorin CalciumEQ 5 mg Base; EQ 25 mg BaseTablet; OralGlaxoSmithKline.
NDA 018353FLAGYL I.V.Metronidazole HydrochlorideEQ 500 mg Base/VialInjectable; InjectionG.D. Searle LLC, a subsidiary of Pfizer Inc.
NDA 018733TALWIN NXNaloxone Hydrochloride; Pentazocine HydrochlorideEQ 0.5 mg Base; EQ 50 mg BaseTablet; OralSanofi-Aventis U.S. LLC.
NDA 019488CARDENENicardipine Hydrochloride20 mg; 30 mgCapsule; OralChiesi USA, Inc.
NDA 019578MEFLOQUINE HYDROCHLORIDEMefloquine Hydrochloride250 mgTablet; OralU.S. Army Walter Reed Army Institute Research.
NDA 019591LARIAMMefloquine Hydrochloride250 mgTablet; OralHoffmann-La Roche Inc.
NDA 019735FLOXINOfloxacin200 mg; 300 mg; 400 mgTablet; OralJanssen Pharmaceuticals, Inc.
NDA 019890STADOLButorphanol Tartrate1 mg/SpraySpray, Metered; NasalBristol-Myers Squibb Co.
NDA 020142CATAFLAMDiclofenac Potassium50 mgTablet; OralNovartis Pharmaceuticals Corp.
NDA 020254VOLTAREN-XRDiclofenac Sodium100 mgExtended-Release Tablet; OralDitto.
NDA 020312UNIVASCMoexipril Hydrochloride7.5 mg; 15 mgTablet; OralUCB, Inc.
NDA 020346ZYRTECCetirizine Hydrochloride5 mg/5 mLSyrup; OralJohnson & Johnson Consumer Inc.
NDA 020584LODINE XLEtodolac400 mg; 500 mg; 600 mgExtended-Release Tablet; OralWyeth Pharmaceuticals Inc.
NDA 020625ALLEGRAFexofenadine Hydrochloride60 mgCapsule; OralSanofi-Aventis U.S. LLC.
NDA 020729UNIRETICHydro chlorothiazide; Moexipril Hydrochloride12.5 mg/7.5 mg; 12.5 mg/15 mg; 25 mg/15 mgTablet; OralUCB, Inc.
NDA 021066ZADITORKetotifen FumarateEQ 0.025% BaseSolution/Drops; OphthalmicAlcon Pharmaceuticals, Ltd.
NDA 021224RAZADYNEGalantamine Hydrobromide4 mg/mLSolution; OralJanssen Pharmaceuticals, Inc.
NDA 021378COMBUNOXIbuprofen; Oxycodone Hydrochloride400 mg; 5 mgTablet; OralForest Laboratories, Inc.
NDA 021473CIPRO XRCiprofloxacin; Ciprofloxacin Hydrochloride212.6 mg; EQ 287.5 mg Base; 425.2 mg; EQ 574.9 mg BaseExtended-Release Tablet; OralBayer HealthCare Pharmaceuticals, Inc.
NDA 021606ZEMPLARParicalcitol4 micrograms (mcg)Capsule; OralAbbVie Inc.
NDA 021729ABILIFYAripiprazole10 mg and 15 mgTablet, Orally Disintegrating; OralOtsuka Pharmaceutical Co., Ltd.
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NDA 050072PENBRITIN-SAmpicillin SodiumEQ 125 mg Base/Vial; EQ 250 mg Base/Vial; EQ 500 mg Base/Vial; EQ 1 gram (g) Base/Vial; EQ 2 g Base/Vial; EQ 4 g Base/VialInjectable; InjectionWyeth Ayerst Laboratories.
NDA 050309POLYCILLIN-NAmpicillin SodiumEQ 125 mg Base/Vial; EQ 250 mg Base/Vial; EQ 500 mg Base/Vial; EQ 1 g Base/Vial; EQ 2 g Base/VialInjectable; InjectionBristol Laboratories Inc.
NDA 050674VANTINCefpodoxime ProxetilEQ 100 mg Base; EQ 200 mg BaseTablet; OralPharmacia and Upjohn Co.
ANDA 064170CEFAZOLIN SODIUMCefazolin SodiumEQ 10 g Base/Vial; EQ 20 g Base/VialInjectable; InjectionFresenius Kabi USA, LLC.
ANDA 075406OGESTREL 0.5/50-21Ethinyl Estradiol; Norgestrel0.05 mg; 0.5 mgTablet; Oral-21Watson Laboratories, Inc.
ANDA 085106PERCOCETAcetaminophen; Oxycodone Hydrochloride325 mg; 5 mgTablet; OralVintage Pharmaceuticals LLC.
ANDA 089351ROXICETAcetaminophen; Oxycodone Hydrochloride325 mg/5 mL; 5 mg/5 mLSolution; OralWest-Ward Pharmaceuticals International Ltd.
ANDA 089456PERPHENAZINEPerphenazine8 mgTablet; OralANI Pharmaceuticals, Inc.
ANDA 089457PERPHENAZINEPerphenazine16 mgTablet; OralTeva Pharmaceuticals USA.
ANDA 089707PERPHENAZINEPerphenazine2 mgTablet; OralDitto.
ANDA 089708PERPHENAZINEPerphenazine4 mgTablet; OralDo.

FDA has reviewed its records and, under § 314.161, has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. Accordingly, the Agency will continue to list the drug products listed in this document in the “Discontinued Drug Product List” section of the Orange Book. The “Discontinued Drug Product List” identifies, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness.

Approved ANDAs that refer to the NDAs and ANDAs listed in this document are unaffected by the discontinued marketing of the products subject to those NDAs and ANDAs. Additional ANDAs that refer to these products may also be approved by the Agency if they comply with relevant legal and regulatory requirements. If FDA determines that labeling for these drug products should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling.

This is not a significant regulatory action subject to Executive Order 12866, and does not impose any additional burden on regulated entities.

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Dated: April 24, 2017.

Anna K. Abram,

Deputy Commissioner for Policy, Planning, Legislation, and Analysis.

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[FR Doc. 2017-08582 Filed 4-27-17; 8:45 am]