Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020958
Company: KENVUE BRANDS
Company: KENVUE BRANDS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PEPCID COMPLETE | CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE | 800MG;10MG;165MG | TABLET, CHEWABLE;ORAL | Over-the-counter | None | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 10/16/2000 | ORIG-1 | Approval | Type 4 - New Combination | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20958lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20958ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-958_Pepcid.html |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/30/2025 | SUPPL-44 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020958Orig1s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/020958Orig1s044ltr..pdf | |
| 02/11/2025 | SUPPL-43 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020958Orig1s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/020958Orig1s043ltr.pdf | |
| 01/17/2025 | SUPPL-42 | Manufacturing (CMC)-Facility |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020958Orig1s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/020958Orig1s042ltr.pdf | |
| 01/31/2025 | SUPPL-41 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020958Orig1s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/020958Orig1s041ltr.pdf | |
| 06/11/2019 | SUPPL-29 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020958Orig1s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020958Orig1s029ltr.pdf | |
| 04/09/2019 | SUPPL-28 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020958Orig1s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020958Orig1s028ltr.pdf | |
| 12/21/2018 | SUPPL-27 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020958Orig1s027Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020958Orig1s027Ltr.pdf | |
| 06/08/2016 | SUPPL-25 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020958Orig1s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020958Orig1s025ltr.pdf | |
| 07/14/2015 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/20/2014 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/07/2013 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/30/2013 | SUPPL-18 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020958Orig1s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020958Orig1s018ltr.pdf | |
| 04/01/2013 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/18/2008 | SUPPL-15 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020958s015ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/020958Orig1s015.pdf |
| 06/09/2006 | SUPPL-13 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020958s013LTR.pdf |
| 07/18/2005 | SUPPL-12 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020958s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020958s012ltr.pdf | |
| 10/27/2004 | SUPPL-10 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20325s017,20801s010,20902s007,20958s010ltr.pdf |
| 11/05/2003 | SUPPL-7 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20958slr007ltr.pdf |
| 11/22/2002 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/06/2001 | SUPPL-2 | Manufacturing (CMC)-Formulation |
Label (PDF)
Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001//20958s2lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020958_S002_PEPCIDTOC.html | |
| 09/24/2001 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/30/2025 | SUPPL-44 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020958Orig1s044lbl.pdf | |
| 02/11/2025 | SUPPL-43 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020958Orig1s043lbl.pdf | |
| 02/11/2025 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020958Orig1s043lbl.pdf | |
| 01/31/2025 | SUPPL-41 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020958Orig1s041lbl.pdf | |
| 01/17/2025 | SUPPL-42 | Manufacturing (CMC)-Facility | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020958Orig1s042lbl.pdf | |
| 06/11/2019 | SUPPL-29 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020958Orig1s029lbl.pdf | |
| 04/09/2019 | SUPPL-28 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020958Orig1s028lbl.pdf | |
| 12/21/2018 | SUPPL-27 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020958Orig1s027Lbl.pdf | |
| 06/08/2016 | SUPPL-25 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020958Orig1s025lbl.pdf | |
| 07/30/2013 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020958Orig1s018lbl.pdf | |
| 07/18/2005 | SUPPL-12 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020958s012lbl.pdf | |
| 11/06/2001 | SUPPL-2 | Manufacturing (CMC)-Formulation | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001//20958s2lbl.pdf | |
| 10/16/2000 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20958lbl.pdf |
PEPCID COMPLETE
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
TABLET, CHEWABLE;ORAL; 800MG;10MG;165MG
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE | 800MG;10MG;165MG | TABLET, CHEWABLE;ORAL | Over-the-counter | No | 077355 | PERRIGO R AND D |
| PEPCID COMPLETE | CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE | 800MG;10MG;165MG | TABLET, CHEWABLE;ORAL | Over-the-counter | Yes | 020958 | KENVUE BRANDS |