MYLAN-FAMOTIDINE DIN 02196026
Health Canada record
| Active ingredient(s) | FAMOTIDINE 40 MG |
|---|---|
| Dosage form | Tablet |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | A02BA03 FAMOTIDINE |
| Original market date | 31-Dec-1995 |
| Current status date | 07-Feb-2018 |
| Source | Health Canada DPD |
Establishment licence of the holder
Mylan Pharmaceuticals ULC — licence 101774, currently licensed, last inspection rating C (2026-02-24).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing FAMOTIDINE
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02538350 | ACID CONTROLLER MAXIMUM STRENGTH | ANGITA PHARMA INC. | Tablet | FAMOTIDINE 20 MG | Marketed |
| 02509970 | AG-FAMOTIDINE | ANGITA PHARMA INC. | Tablet | FAMOTIDINE 20 MG | Marketed |
| 02509989 | AG-FAMOTIDINE | ANGITA PHARMA INC. | Tablet | FAMOTIDINE 40 MG | Marketed |
| 02351110 | FAMOTIDINE | SANIS HEALTH INC | Tablet | FAMOTIDINE 40 MG | Marketed |
| 02351102 | FAMOTIDINE | SANIS HEALTH INC | Tablet | FAMOTIDINE 20 MG | Marketed |
| 02244133 | FAMOTIDINE INJECTION | FRESENIUS KABI CANADA LTD | Solution | FAMOTIDINE 10 MG | Approved |
| 02247745 | FAMOTIDINE OMEGA -(WITH PRESERVATIVE,BENZYL ALCOHOL) | OMEGA LABORATORIES LIMITED | Solution | FAMOTIDINE 10 MG | Marketed |
| 02247735 | FAMOTIDINE OMEGA -(WITHOUT PRESERVATIVE) | OMEGA LABORATORIES LIMITED | Solution | FAMOTIDINE 10 MG | Marketed |
| 02507749 | JAMP FAMOTIDINE | JAMP PHARMA CORPORATION | Tablet | FAMOTIDINE 20 MG | Marketed |
| 02507757 | JAMP FAMOTIDINE | JAMP PHARMA CORPORATION | Tablet | FAMOTIDINE 40 MG | Marketed |
| 02273357 | MAXIMUM STRENGTH PEPCID AC | KENVUE CANADA INC. | Tablet | FAMOTIDINE 20 MG | Marketed |
| 02185938 | PEPCID AC | KENVUE CANADA INC. | Tablet | FAMOTIDINE 10 MG | Marketed |
| 02243053 | PEPCID COMPLETE | KENVUE CANADA INC. | Tablet (Chewable) | FAMOTIDINE 10 MG; CALCIUM CARBONATE 800 MG; MAGNESIUM HYDROXIDE 165 MG | Marketed |
| 02022141 | TEVA-FAMOTIDINE | TEVA CANADA LIMITED | Tablet | FAMOTIDINE 40 MG | Marketed |
| 02022133 | TEVA-FAMOTIDINE | TEVA CANADA LIMITED | Tablet | FAMOTIDINE 20 MG | Marketed |
| 02296098 | ACID CONTROL | APOTEX INC | Tablet | FAMOTIDINE 20 MG | Dormant |
| 02231400 | ACID CONTROL | TEVA CANADA LIMITED | Tablet | FAMOTIDINE 10 MG | Cancelled Post Market |
| 02231567 | ACID CONTROL | PENDOPHARM DIVISION OF PHARMASCIENCE INC | Tablet | FAMOTIDINE 10 MG | Cancelled Post Market |
| 02237223 | ACID CONTROL | VITA HEALTH PRODUCTS INC | Tablet | FAMOTIDINE 10 MG | Cancelled Post Market |
| 02240414 | ACID CONTROL | APOTEX INC | Tablet | FAMOTIDINE 10 MG | Dormant |
| 02237004 | ACT | NOVOPHARM LIMITED | Tablet | FAMOTIDINE 10 MG | Cancelled Pre Market |
| 02231119 | APO-FAMOTIDINE | APOTEX INC | Tablet | FAMOTIDINE 10 MG | Dormant |
| 02244998 | APO-FAMOTIDINE INJECTABLE | APOTEX INC | Solution | FAMOTIDINE 10 MG | Cancelled Post Market |
| 02244888 | APO-FAMOTIDINE INJECTABLE | APOTEX INC | Solution | FAMOTIDINE 10 MG | Cancelled Post Market |
| 01953842 | APO-FAMOTIDINE TAB 20MG USP | APOTEX INC | Tablet | FAMOTIDINE 20 MG | Dormant |
| 01953834 | APO-FAMOTIDINE TAB 40MG USP | APOTEX INC | Tablet | FAMOTIDINE 40 MG | Cancelled Post Market |
| 02257645 | BCI FAMOTIDINE | BAKER CUMMINS INC | Tablet | FAMOTIDINE 20 MG | Cancelled Pre Market |
| 02257653 | BCI FAMOTIDINE | BAKER CUMMINS INC | Tablet | FAMOTIDINE 40 MG | Cancelled Pre Market |
| 02238212 | FAMOTIDINE 10MG | LABORATOIRE RIVA INC. | Tablet | FAMOTIDINE 10 MG | Cancelled Pre Market |
| 02383098 | FAMOTIDINE INJECTION | MYLAN PHARMACEUTICALS ULC | Solution | FAMOTIDINE 10 MG | Cancelled Pre Market |
| 02383071 | FAMOTIDINE INJECTION | MYLAN PHARMACEUTICALS ULC | Solution | FAMOTIDINE 10 MG | Cancelled Pre Market |
| 02246364 | FAMOTIDINE INJECTION | HOSPIRA HEALTHCARE ULC | Solution | FAMOTIDINE 10 MG | Cancelled Pre Market |
| 02247799 | FAMOTIDINE IV INJECTION | TEVA CANADA LIMITED | Solution | FAMOTIDINE 10 MG | Cancelled Pre Market |
| 02247800 | FAMOTIDINE IV INJECTION | TEVA CANADA LIMITED | Solution | FAMOTIDINE 10 MG | Cancelled Pre Market |
| 02248223 | FAMOTIDINE TABLETS | IVAX PHARMACEUTICALS INCORPORATED | Tablet | FAMOTIDINE 40 MG | Cancelled Pre Market |
| 02248222 | FAMOTIDINE TABLETS | IVAX PHARMACEUTICALS INCORPORATED | Tablet | FAMOTIDINE 20 MG | Cancelled Pre Market |
| 02241372 | FAMOTIDINE-20 | PRO DOC LIMITEE | Tablet | FAMOTIDINE 20 MG | Cancelled Post Market |
| 02241373 | FAMOTIDINE-40 | PRO DOC LIMITEE | Tablet | FAMOTIDINE 40 MG | Cancelled Post Market |
| 02232293 | MAALOX H2 ACID CONTROLLER | APOTEX INC | Tablet | FAMOTIDINE 10 MG | Cancelled Post Market |
| 02196018 | MYLAN-FAMOTIDINE | MYLAN PHARMACEUTICALS ULC | Tablet | FAMOTIDINE 20 MG | Cancelled Post Market |
| 02347644 | NTP-FAMOTIDINE | TEVA CANADA LIMITED | Tablet | FAMOTIDINE 40 MG | Cancelled Pre Market |
| 02347636 | NTP-FAMOTIDINE | TEVA CANADA LIMITED | Tablet | FAMOTIDINE 20 MG | Cancelled Pre Market |
| 02024195 | NU-FAMOTIDINE TAB 20MG | NU-PHARM INC | Tablet | FAMOTIDINE 20 MG | Cancelled Post Market |
| 02024209 | NU-FAMOTIDINE TAB 40MG | NU-PHARM INC | Tablet | FAMOTIDINE 40 MG | Cancelled Post Market |
| 02238343 | PENTA-FAMOTIDINE | PENTAPHARM LTD. | Tablet | FAMOTIDINE 40 MG | Cancelled (Unreturned Annual) |
| 02238342 | PENTA-FAMOTIDINE | PENTAPHARM LTD. | Tablet | FAMOTIDINE 20 MG | Cancelled (Unreturned Annual) |
| 02241322 | PEPCID AC | MCNEIL CONSUMER HEALTHCARE DIVISION OF JOHNSON & JOHNSON INC | Tablet | FAMOTIDINE 10 MG | Cancelled Pre Market |
| 02185911 | PEPCID AC (CHEWABLE TAB) - 10MG | MERCK CANADA INC | Tablet | FAMOTIDINE 10 MG | Cancelled Post Market |
| 00728128 | PEPCID I.V. 10MG/ML | MERCK CANADA INC | Solution | FAMOTIDINE 10 MG | Cancelled Post Market |
| 00710121 | PEPCID TAB 20MG | MERCK CANADA INC | Tablet | FAMOTIDINE 20 MG | Cancelled Post Market |
| 00710113 | PEPCID TAB 40MG | MERCK CANADA INC | Tablet | FAMOTIDINE 40 MG | Cancelled Post Market |
| 02231104 | PEPTIC GUARD | MYLAN PHARMACEUTICALS ULC | Tablet | FAMOTIDINE 10 MG | Cancelled Post Market |
| 02242327 | RATIO-FAMOTIDINE 20MG | RATIOPHARM INC DIVISION OF TEVA CANADA LIMITED | Tablet | FAMOTIDINE 20 MG | Cancelled Post Market |
| 02242328 | RATIO-FAMOTIDINE 40MG | RATIOPHARM INC DIVISION OF TEVA CANADA LIMITED | Tablet | FAMOTIDINE 40 MG | Cancelled Post Market |
| 02240622 | RHOXAL-FAMOTIDINE | RHOXALPHARMA INC | Tablet | FAMOTIDINE 20 MG | Cancelled Post Market |
| 02240623 | RHOXAL-FAMOTIDINE | RHOXALPHARMA INC | Tablet | FAMOTIDINE 40 MG | Cancelled Post Market |
| 02242154 | RIVA-FAMOTIDINE 20 MG | LABORATOIRE RIVA INC. | Tablet | FAMOTIDINE 20 MG | Cancelled Post Market |
| 02242155 | RIVA-FAMOTIDINE 40 MG | LABORATOIRE RIVA INC. | Tablet | FAMOTIDINE 40 MG | Cancelled Post Market |
| 02237148 | ULCIDINE | VALEANT CANADA LP / VALEANT CANADA S.E.C. | Tablet | FAMOTIDINE 20 MG | Cancelled Post Market |
| 02237149 | ULCIDINE | VALEANT CANADA LP / VALEANT CANADA S.E.C. | Tablet | FAMOTIDINE 40 MG | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 10297 | 2009-06-25 | New Drug Submission (NDS) | New manufacturer and product name |
| 5015 | 1995-11-22 | New Drug Submission (NDS) |
International API supply for FAMOTIDINE
14 valid EDQM Certificates of Suitability from 14 holders. 18 active FDA Drug Master Files.
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