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 Drug Recalls 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… Dicyclomine Hydrochloride Capsules USP, 10 mg Mylan ANDA 40-319 9/14/99 9/14/99 Dicyclomine Hydrochloride Capsules USP, 20 mg Mylan ANDA 40-317 9/17/99 9/14/99 Dicyclomine Hydrochloride Injection USP, 20 mg, Bedford ANDA 40-465 6/30/03 Dicyclomine Hydrochloride Tablets USP, 20 mg Lannett Company ANDA 40-230 DICYCLOMINE HYDROCHLORIDE Capsule; 10MG BENTYL AVENTIS 084285 DICYCLOMINE HYDROCHLORIDE Capsule; 10MG DICYCLOMINE HCL LANNETT 040319 DICYCLOMINE HYDROCHLORIDE Capsule; 10MG DICYCLOMINE HCL Mylan 085082 DICYCLOMINE HYDROCHLORIDE Capsule; 10MG DICYCLOMINE HCL Watson 040204 DICYCLOMINE HYDROCHLORIDE Capsule; 10MG DICYCLOMINE HCL West Ward 008370 DICYCLOMINE HYDROCHLORIDE Injection 10MG/ML BENTYL AVENTIS 008370 DICYCLOMINE HYDROCHLORIDE Injection 10MG/ML BENTYL PRESERVATIVE FREE AVENTIS 040465 DICYCLOMINE HYDROCHLORIDE Injection 10MG/ML DICYCLOMINE HCL (PRESERVATIVE-FREE) Bedford 007961 DICYCLOMINE HYDROCHLORIDE Syrup; 10MG/5ML BENTYL AVENTIS 007409 DICYCLOMINE HYDROCHLORIDE Tablet; 20MG BENTYL AVENTIS 040230 DICYCLOMINE HYDROCHLORIDE Tablet; 20MG DICYCLOMINE HCL LANNETT 040317 DICYCLOMINE HYDROCHLORIDE Tablet; 20MG DICYCLOMINE HCL Mylan 085223 DICYCLOMINE HYDROCHLORIDE Tablet; 20MG DICYCLOMINE HCL Watson 040161 DICYCLOMINE HYDROCHLORIDE Tablet; 20MG DICYCLOMINE HCL West Ward | Dicyclomine Syrup, Mikart Inc., Approval | Bentyl (dicyclomine hydrochloride) Capsules, Axcan Scandiapharm, Labeling Revision | Bentyl (dicyclomine hydrochloride) Tablets, Axcan Scandiapharm, Labeling Revision | Bentyl (dicyclomine hydrochloride), Injection, Axcan Scandiapharm, Labeling Revision ^ 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 | News Feed for each API | DMF Index | Pharma Job Search | Pharma Company News © 2008 Betterchem.com