FDA Approval Activities for this Drug…

Demerol (meperidine HCl) Tablets & Syrup, Sanofi-Synthelabo NDA 5-010/S-048 5/15/03 7/9/03 Demerol (meperidine HCl, USP), Sanofi-Synthelabo NDA 5-010/S-047 Meperidine Hydrochloride Tablets USP, 50 mg & 100 mg, Caraco Pharmaceutical Ltd. ANDA 40-446 8/8/02 4/9/03 Meperidine Hydrochloride Tablets USP, 50 mg & 100 mg, Mallinckrodt ANDA 40-352 6/13/00 6/16/00 8/4/03 Meperidine Hydrochloride Tablets USP, 50 mg & 100 mg. Amide Pharmaceutical, ANDA 40-331 5/28/99 6/1/99 Meperidine Hydrochloride Tablets USP, 50 mg & 100 mg. Duramed ANDA 40-318 10/5/99 10/15/99 Meperidine Hydrochloride Tablets USP, 50 mg & 100 mg. Vintage ANDA 40-191 12/17/98 12/29 8/1/03 Meperidine Hydrochloride Injection USP, 10 mg/mL, 30 mL single dose vials Injection, Faulding Pharmaceutical Co. ANDA 40-305 ATROPINE SULFATE; MEPERIDINE HYDROCHLORIDE Injection 0.4MG/ML;100MG/ML ATROPINE AND DEMEROL Abbott 087853 ATROPINE SULFATE; MEPERIDINE HYDROCHLORIDE Injection 0.4MG/ML;50MG/ML ATROPINE AND DEMEROL Abbott 087847 ATROPINE SULFATE; MEPERIDINE HYDROCHLORIDE Injection 0.4MG/ML;75MG/ML ATROPINE AND DEMEROL Abbott 021171 MEPERIDINE HYDROCHLORIDE Injection 100MG/ML DEMEROL Abbott 088432 MEPERIDINE HYDROCHLORIDE Injection 10MG/ML MEPERIDINE HCL PRESERVATIVE FREE Abbott 021171 MEPERIDINE HYDROCHLORIDE Injection 25MG/ML DEMEROL Abbott 021171 MEPERIDINE HYDROCHLORIDE Injection 50MG/ML DEMEROL Abbott 021171 MEPERIDINE HYDROCHLORIDE Injection 75MG/ML DEMEROL Abbott 081002 MEPERIDINE HYDROCHLORIDE Injection 10MG/ML MEPERIDINE HCL PRESERVATIVE FREE ASTRAZENECA 080455 MEPERIDINE HYDROCHLORIDE Injection 100MG/ML MEPERIDINE HCL Baxter CORP 080455 MEPERIDINE HYDROCHLORIDE Injection 25MG/ML MEPERIDINE HCL Baxter CORP 080455 MEPERIDINE HYDROCHLORIDE Injection 50MG/ML MEPERIDINE HCL Baxter CORP 080455 MEPERIDINE HYDROCHLORIDE Injection 75MG/ML MEPERIDINE HCL Baxter CORP 080445 MEPERIDINE HYDROCHLORIDE Injection 100MG/ML MEPERIDINE HCL ELKINS SINN 080445 MEPERIDINE HYDROCHLORIDE Injection 25MG/ML MEPERIDINE HCL ELKINS SINN 080445 MEPERIDINE HYDROCHLORIDE Injection 50MG/ML MEPERIDINE HCL ELKINS SINN 080445 MEPERIDINE HYDROCHLORIDE Injection 75MG/ML MEPERIDINE HCL ELKINS SINN 040305 MEPERIDINE HYDROCHLORIDE Injection 10MG/ML MEPERIDINE HCL PRESERVATIVE FREE Faulding 081309 MEPERIDINE HYDROCHLORIDE Injection 10MG/ML MEPERIDINE HCL PRESERVATIVE FREE INTL MEDICATION 040163 MEPERIDINE HYDROCHLORIDE Injection 10MG/ML MEPERIDINE HCL PRESERVATIVE FREE Mallinckrodt 073445 MEPERIDINE HYDROCHLORIDE Injection 100MG/ML MEPERIDINE HCL STERIS 073443 MEPERIDINE HYDROCHLORIDE Injection 10MG/ML MEPERIDINE HCL PRESERVATIVE FREE STERIS 073444 MEPERIDINE HYDROCHLORIDE Injection 50MG/ML MEPERIDINE HCL STERIS 088744 MEPERIDINE HYDROCHLORIDE Syrup; 50MG/5ML MEPERIDINE HCL Roxane 005010 MEPERIDINE HYDROCHLORIDE Syrup; 50MG/5ML DEMEROL SANOFI SYNTHELABO 040331 MEPERIDINE HYDROCHLORIDE Tablet; 100MG MEPERIDINE HCL Amide 040331 MEPERIDINE HYDROCHLORIDE Tablet; 50MG MEPERIDINE HCL Amide 080448 MEPERIDINE HYDROCHLORIDE Tablet; 100MG MEPERIDINE HCL AXIOM 080448 MEPERIDINE HYDROCHLORIDE Tablet; 50MG MEPERIDINE HCL AXIOM 088640 MEPERIDINE HYDROCHLORIDE Tablet; 100MG MEPERIDINE HCL Barr 088639 MEPERIDINE HYDROCHLORIDE Tablet; 50MG MEPERIDINE HCL Barr 040446 MEPERIDINE HYDROCHLORIDE Tablet; 100MG MEPERIDINE HCL Caraco 040446 MEPERIDINE HYDROCHLORIDE Tablet; 50MG MEPERIDINE HCL Caraco 040318 MEPERIDINE HYDROCHLORIDE Tablet; 100MG MEPERIDINE HCL DURAMED Barr 040318 MEPERIDINE HYDROCHLORIDE Tablet; 50MG MEPERIDINE HCL DURAMED Barr 040352 MEPERIDINE HYDROCHLORIDE Tablet; 100MG MEPERIDINE HCL Mallinckrodt 040352 MEPERIDINE HYDROCHLORIDE Tablet; 50MG MEPERIDINE HCL Mallinckrodt 040110 MEPERIDINE HYDROCHLORIDE Tablet; 100MG MEPERIDINE HCL Roxane 040110 MEPERIDINE HYDROCHLORIDE Tablet; 50MG MEPERIDINE HCL Roxane 005010 MEPERIDINE HYDROCHLORIDE Tablet; 100MG DEMEROL SANOFI SYNTHELABO 005010 MEPERIDINE HYDROCHLORIDE Tablet; 50MG DEMEROL SANOFI SYNTHELABO 040191 MEPERIDINE HYDROCHLORIDE Tablet; 100MG MEPERIDINE HCL Vintage 040191 MEPERIDINE HYDROCHLORIDE Tablet; 50MG MEPERIDINE HCL Vintage 040186 MEPERIDINE HYDROCHLORIDE Tablet; 100MG MEPERIDINE HCL Watson 040186 MEPERIDINE HYDROCHLORIDE Tablet; 50MG MEPERIDINE HCL Watson

For the latest approval information, please see the main page.