Details for New Drug Application (NDA): 020745
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NDA 020745 describes ZANTAC 75, which is a drug marketed by Chattem Sanofi and is included in two NDAs. Additional details are available on the ZANTAC 75 profile page.
The generic ingredient in ZANTAC 75 is ranitidine hydrochloride. There are forty-three drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the ranitidine hydrochloride profile page.
The generic ingredient in ZANTAC 75 is ranitidine hydrochloride. There are forty-three drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the ranitidine hydrochloride profile page.
Summary for 020745
| Tradename: | ZANTAC 75 |
| Applicant: | Chattem Sanofi |
| Ingredient: | ranitidine hydrochloride |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EFFERVESCENT;ORAL | Strength | EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Feb 26, 1998 | TE: | RLD: | Yes | |||||
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