Key Data Files for this Active Pharmaceutical Ingredient:

Drug Master Files, 21 CFR, and other industry portals Patent/Exclusivity data file Drug Approval Drug Safety Freedom of Information Federal Register pages Pharma Companies Pharmacopeial Information Preferred API Supplier (Clients Only)

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, locate this drug using this index.