Content specific to this active ingredient… Drug Information Prescribing and patient information from leading authorities Drug Master Files Type 2 master files on file at the FDA Safety Information For prescription drugs containing this active ingredient Exclusivity Patent and market exclusivity data Federal Register FR search results for this API FDA Approved Labelling Information found in this drug's package inserts Research Links Chemical identification and research citations Title 21 Code of Federal Regulations FDA regulations for this API

FDA Approval Activities for this Drug… Nicardipine Hydrochloride Capsules, 20 mg & 20 mg. Genpharm, ANDA 74-928 NICARDIPINE HYDROCHLORIDE Capsule, Extended Release; 30MG CARDENE SR ROCHE PALO | 020005 NICARDIPINE HYDROCHLORIDE Capsule, Extended Release; 45MG CARDENE SR ROCHE PALO | 020005 NICARDIPINE HYDROCHLORIDE Capsule, Extended Release; 60MG CARDENE SR ROCHE PALO | 074928 NICARDIPINE HYDROCHLORIDE Capsule; 20MG NICARDIPINE HCL Genpharm | 074928 NICARDIPINE HYDROCHLORIDE Capsule; 30MG NICARDIPINE HCL Genpharm | 074439 NICARDIPINE HYDROCHLORIDE Capsule; 20MG NICARDIPINE HCL Ivax | 074439 NICARDIPINE HYDROCHLORIDE Capsule; 30MG NICARDIPINE HCL Ivax | 074642 NICARDIPINE HYDROCHLORIDE Capsule; 20MG NICARDIPINE HCL Mylan | 074642 NICARDIPINE HYDROCHLORIDE Capsule; 30MG NICARDIPINE HCL Mylan | 019488 NICARDIPINE HYDROCHLORIDE Capsule; 20MG CARDENE ROCHE PALO | 019488 NICARDIPINE HYDROCHLORIDE Capsule; 30MG CARDENE ROCHE PALO | 074540 NICARDIPINE HYDROCHLORIDE Capsule; 20MG NICARDIPINE HCL Teva | 074540 NICARDIPINE HYDROCHLORIDE Capsule; 30MG NICARDIPINE HCL Teva | 074670 NICARDIPINE HYDROCHLORIDE Capsule; 20MG NICARDIPINE HCL Watson | 074670 NICARDIPINE HYDROCHLORIDE Capsule; 30MG NICARDIPINE HCL Watson | 019734 NICARDIPINE HYDROCHLORIDE Injection 2.5MG/ML CARDENE ROCHE PALO | Nicardipine Hydrochloride Capsules, Barr Labs, Facility Addition | Cardene I.V. (nicardipine hydrochloride), PDL BioPharma, Labeling Revision | Nicardipine Hydrochloride Injection, Teva Parenteral Medicines, Approval | Cardene (nicardipine hydrochloride) Injection, EKR Therapeutics, Inc., Formulation Revision | Nicardipine Hydrochloride Injection, Teva Parenteral Medicines, Labeling Revision | Nicardipine Hydrochloride Injection, PharmaForce, Inc., Approval | Nicardipine Hydrochloride Injection, GeneraMedix, Inc., Approval | Nicardipine Hydrochloride Injection, Navinta, LLC., Approval | Nicardipine Hydrochloride Injection, Sun Pharma Global Inc., Approval | Nicardipine Hydrochloride Injection, Wockhardt Limited, Approval | Cardene (nicardipine hydrochloride) Injection, EKR Therapeutics, Inc., Labeling Revision | Nicardipine Hydrochloride Injection, Bedford Laboratories, Approval | Cardene (nicardipine hydrochloride) Injection, EKR Therapeutics., Labeling Revision | Nicardipine Hydrochloride, nicardipine hydrochloride, Injectable; Injection, Exela Pharma Science, Manufacturing Change or Addition | Cardene, nicardipine hydrochloride, Injectable; Injection, Ekr Therap, Manufacturing Change or Addition | Cardene In 0.83% Sodium Chloride In Plastic Container, nicardipine hydrochloride, Injectable; Intravenous, Ekr Therap, Manufacturing Change or Addition | Cardene In 0.86% Sodium Chloride In Plastic Container, nicardipine hydrochloride, Injectable; Intravenous, Ekr Therap, Manufacturing Change or Addition | Cardene In 4.8% Dextrose In Plastic Container, nicardipine hydrochloride, Injectable; Intravenous, Ekr Therap, Manufacturing Change or Addition | Cardene In 5.0% Dextrose In Plastic Container, nicardipine hydrochloride, Injectable; Intravenous, Ekr Therap, Manufacturing Change or Addition ^ FDA's latest approval appears at the bottom of this list. ^                                                                       A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U-Z Health Topics | For Industry | DMF Index | Pharma Job Search | Pharma Company News | Best Phone © 2013 Betterchem.com