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… Nizatidine Capsules USP, 150 & 300 mg, Torpharm ANDA 76-383 1/23/03 Nizatidine Capsules USP, 150 & 300 mg, Eon Labs Manufacturing, ANDA 76-178 7/5/02 Nizatidine Capsules USP, 150 & 300 mg, Eon Labs Manufacturing, ANDA 76-178 3/12/02 4/11/03 Nizatidine Capsules USP, 150 mg & 300 mg, Genpharm ANDA 75-934 7/9/02 Nizatidine Capsules USP, 150 mg & 300 mg, Genpharm ANDA 75-934 9/28/01 4/16/03 Nizatidine Capsules USP, 150 mg & 300 mg, Mylan ANDA 75-806 7/5/02 Nizatidine Capsules USP, 150 mg & 300 mg, Mylan ANDA 75-806 11/15/00 11/17/00 Nizatidine Capsules USP, 150 mg & 300 mg, Teva ANDA 75-668 9/12/02 Nizatidine Capsules USP, 150 mg & 300 mg, Watson, ANDA 75-616 7/9/02 Nizatidine Capsules USP, 150 mg & 300 mg, Danbury Pharmacal, ANDA 75-616 10/25/00 11/7/00 Nizatidine Capsules USP, 150 mg & 300 mg Zenith Goldline ANDA 75-461 7/8/02 Nizatidine Capsules USP, 150 mg & 300 mg Zenith Goldline ANDA 75-461 NIZATIDINE Capsule; 150MG NIZATIDINE Eon 076178 NIZATIDINE Capsule; 300MG NIZATIDINE Eon 075934 NIZATIDINE Capsule; 150MG NIZATIDINE Genpharm 075934 NIZATIDINE Capsule; 300MG NIZATIDINE Genpharm 075806 NIZATIDINE Capsule; 150MG NIZATIDINE Mylan 075806 NIZATIDINE Capsule; 300MG NIZATIDINE Mylan 019508 NIZATIDINE Capsule; 150MG AXID RELIANT 019508 NIZATIDINE Capsule; 300MG AXID RELIANT 075668 NIZATIDINE Capsule; 150MG NIZATIDINE Teva 075668 NIZATIDINE Capsule; 300MG NIZATIDINE Teva 076383 NIZATIDINE Capsule; 150MG NIZATIDINE Torpharm 076383 NIZATIDINE Capsule; 300MG NIZATIDINE Torpharm 075616 NIZATIDINE Capsule; 150MG NIZATIDINE Watson 075616 NIZATIDINE Capsule; 300MG NIZATIDINE Watson 075461 NIZATIDINE Capsule; 150MG NIZATIDINE ZENITH GOLDLINE 075461 NIZATIDINE Capsule; 300MG NIZATIDINE ZENITH GOLDLINE   For the latest approval information, locate this drug using this index.