Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020520
Company: CHATTEM SANOFI
Company: CHATTEM SANOFI
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ZANTAC 75 | RANITIDINE HYDROCHLORIDE | EQ 75MG BASE | TABLET;ORAL | Discontinued | None | Yes | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 12/19/1995 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/18/2019 | SUPPL-38 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020520Orig1s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020520Orig1s038ltr.pdf | |
| 04/04/2019 | SUPPL-37 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020520Orig1s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020520Orig1s037ltr.pdf | |
| 07/27/2016 | SUPPL-33 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021698Oirg1s023,020520Orig1s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021698Orig1s023,020520Orig1s033ltr.pdf | |
| 01/26/2016 | SUPPL-32 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020520Orig1s032LBL.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020520Orig1s032ltr.pdf | |
| 09/24/2015 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/20/2015 | SUPPL-30 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020520Orig1s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020520Orig1s030ltr.pdf | |
| 01/30/2015 | SUPPL-28 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020520Orig1s028lbl_corrected.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020520Orig1s028ltr.pdf | |
| 07/25/2013 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/28/2005 | SUPPL-15 | Labeling |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20520s015ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020520_S015_ZANTAC.pdf |
| 12/03/2002 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/30/2002 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/29/2001 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 11/08/2000 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/07/2000 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/28/2000 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/01/1998 | SUPPL-5 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/08/1997 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/22/1998 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/26/1997 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/08/1998 | SUPPL-1 | Efficacy-New Indication |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20520s1_Zantac.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/18/2019 | SUPPL-38 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020520Orig1s038lbl.pdf | |
| 04/04/2019 | SUPPL-37 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020520Orig1s037lbl.pdf | |
| 07/27/2016 | SUPPL-33 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021698Oirg1s023,020520Orig1s033lbl.pdf | |
| 01/26/2016 | SUPPL-32 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020520Orig1s032LBL.pdf | |
| 11/20/2015 | SUPPL-30 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020520Orig1s030lbl.pdf | |
| 01/30/2015 | SUPPL-28 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020520Orig1s028lbl_corrected.pdf |