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… Videx EC (didanosine) Chewable dispersible buffered tablets, Bristol-Myers Squibb NDA 20-154/S35, S36 9/10/01 4/21/03 Videx EC (didanosine) Chewable dispersible buffered tablets, Bristol-Myers Squibb NDA 20-155/S26 9/10/01 4/21/03 Videx EC (didanosine) Chewable dispersible buffered tablets, Bristol-Myers Squibb NDA 20-155/S27 9/10/01 4/21/03 Videx EC (didanosine) Chewable dispersible buffered tablets, Bristol-Myers Squibb NDA 20-156/S28 9/10/01 4/21/03 Videx EC (didanosine) Chewable dispersible buffered tablets, Bristol-Myers Squibb NDA 20-156/S28 9/10/01 4/21/03 Videx EC (didanosine) Delayed Release Capsules, Bristol-Myers Squibb NDA 21-183/S5/S6 9/26/02 10/2/02 9/27/02 Videx EC (didanosine) Delayed Release Capsules, Bristol-Myers Squibb NDA 21-183/S4 8/5/02 8/12/02 8/5/02 Videx EC (didanosine) Delayed Release Capsules, Bristol-Myers Squibb NDA 21-183/S2 1/29/02 3/6/02 Videx EC (didanosine) Delayed Release Capsules, Bristol-Myers Squibb NDA 21-183/S1 1/28/02 3/6/02 Videx EC, Bristol-Myers Squibb NDA 21-183 10/31/00 1/5/01 Videx EC Indications: in combination with other antiretroviral agents, as indicated for the treatment of HIV-1 infection in adults whose management requires once-daily administration of didanosine or an alternative didanosine formulation. VIDEX (didanosine) Buffered Tablets, Buffered Powder for Solution, & Pediatric Powder, Bristol-Myers Squibb Company NDA 20-154/S-040 & s-041, 20-155/S-030 & S-031, 20-156/S-031 & S-032 9/25/02 10/2/02 9/25/02 VIDEX (didanosine) Buffered Tablets, Buffered Powder for Solution, & Pediatric Powder, & VIDEX® EC (didanosine) Delayed Release Capsules, Bristol-Myers Squibb Company NDA 20-154/S-42, 20-155/S-32, 20-156/S-33 & 21-183/S-7 3/4/03 3/10/03 3/6/03 VIDEX (didanosine) Buffered Tablets, Buffered Powder for Solution, & Pediatric Powder, & VIDEX® EC (didanosine) Delayed Release Capsules, Bristol-Myers Squibb Company NDA 20-154/S-037, 20-155/S-028, 20-156/S-029 & 21-183/S-003 4/1/02 4/8/02 4/2/02 VIDEX (didanosine) chewable/dispersible tablets, Buffered Powder for Solution, and Pediatric Powder for Solution, Bristol-Myers Squibb NDA 20-154/S29, S30 20-155/S21 20-156/S22 DIDANOSINE Capsule, Delayed Rel Pellets; 125MG VIDEX EC BRISTOL MYERS SQUIBB 021183 DIDANOSINE Capsule, Delayed Rel Pellets; 200MG VIDEX EC BRISTOL MYERS SQUIBB 021183 DIDANOSINE Capsule, Delayed Rel Pellets; 250MG VIDEX EC BRISTOL MYERS SQUIBB 021183 DIDANOSINE Capsule, Delayed Rel Pellets; 400MG VIDEX EC BRISTOL MYERS SQUIBB 020155 DIDANOSINE For Solution; 100MG/PACKET VIDEX BRISTOL MYERS SQUIBB 020156 DIDANOSINE For Solution; 10MG/ML VIDEX BRISTOL MYERS SQUIBB 020155 DIDANOSINE For Solution; 167MG/PACKET VIDEX BRISTOL MYERS SQUIBB 020155 DIDANOSINE For Solution; 250MG/PACKET VIDEX BRISTOL MYERS SQUIBB 020154 DIDANOSINE Tablet, Chewable; 100MG VIDEX BRISTOL MYERS SQUIBB 020154 DIDANOSINE Tablet, Chewable; 150MG VIDEX BRISTOL MYERS SQUIBB 020154 DIDANOSINE Tablet, Chewable; 200MG VIDEX BRISTOL MYERS SQUIBB 020154 DIDANOSINE Tablet, Chewable; 25MG VIDEX BRISTOL MYERS SQUIBB 020154 DIDANOSINE Tablet, Chewable; 50MG VIDEX BRISTOL MYERS SQUIBB VIDEX (didanosine) Chewable Tablets, Buffered/Pediatric Powder for Oral Solution, & Delayed-Release Capsules, Bristol-Myers Squibb | Didanosine Tablets, Aurobindo Pharma, Tentative Approval | Videx (didanosine) Buffered Powder for Oral Solution, Bristol-Myers Squibb, Labeling Revision | Videx (didanosine) Chewable/Dispersible Buffered Tablets, Bristol-Myers Squibb, Labeling Revision | Videx (didanosine) Pediatric Powder for Oral Solution, Bristol-Myers Squibb, Labeling Revision | Videx EC (didanosine) Delayed Release Capsules, Bristol-Myers Squibb, Labeling Revision | Didanosine Oral Solution, Aurobindo Pharma, Tentative Approval | Videx (didanosine) Chewable/Dispersible Buffered Tablets, Bristol-Myers Squibb, Labeling Revision | Videx (didanosine) Buffered Powder for Oral Solution, Bristol-Myers Squibb, Labeling Revision | Videx (didanosine) Pediatric Powder for Oral Solution, Bristol-Myers Squibb, Labeling Revision | Videx EC (didanosine) Delayed Release Capsules, Bristol-Myers Squibb, Labeling Revision | Didanosine Oral Solution, Aurobindo Pharma, Approval | Didanosine Delayed-Release Capsules, Aurobindo Pharma, Approval | Didanosine Delayed-Release Capsules, Aurobindo Pharma, Approval | Videx Ec (didanosine) Delayed Release Capsules, Bristol-Myers Squibb Co., Patient Population Altered ^ 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