Documents
Application Sponsors
Marketing Status
| Discontinued | 001 |
| Discontinued | 004 |
Application Products
| 001 | INJECTABLE;INJECTION | 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | PEPCID | FAMOTIDINE |
| 004 | INJECTABLE;INJECTION | 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | PEPCID PRESERVATIVE FREE | FAMOTIDINE |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 1986-11-04 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 1987-04-01 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1987-06-03 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 1988-11-23 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1992-01-07 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 1988-10-28 | |
| LABELING; Labeling | SUPPL | 7 | AP | 1990-11-30 | |
| LABELING; Labeling | SUPPL | 8 | AP | 1990-11-30 | |
| LABELING; Labeling | SUPPL | 9 | AP | 1995-06-29 | |
| LABELING; Labeling | SUPPL | 10 | AP | 1991-12-10 | |
| LABELING; Labeling | SUPPL | 11 | AP | 1997-05-16 | |
| LABELING; Labeling | SUPPL | 12 | AP | 1990-11-30 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1996-05-08 | STANDARD |
| LABELING; Labeling | SUPPL | 16 | AP | 1995-06-29 | STANDARD |
| LABELING; Labeling | SUPPL | 17 | AP | 1995-06-29 | STANDARD |
| LABELING; Labeling | SUPPL | 18 | AP | 1995-06-29 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1996-01-30 | STANDARD |
| LABELING; Labeling | SUPPL | 20 | AP | 1998-08-12 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 1999-05-06 | STANDARD |
| LABELING; Labeling | SUPPL | 22 | AP | 1997-05-16 | STANDARD |
| LABELING; Labeling | SUPPL | 23 | AP | 1997-11-12 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 1997-12-19 | STANDARD |
| LABELING; Labeling | SUPPL | 25 | AP | 1999-01-28 | STANDARD |
| LABELING; Labeling | SUPPL | 26 | AP | 1999-03-18 | STANDARD |
| LABELING; Labeling | SUPPL | 27 | AP | 2001-04-25 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 28 | AP | 2002-06-06 | STANDARD |
| LABELING; Labeling | SUPPL | 29 | AP | 2001-03-14 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 30 | AP | 2002-08-01 | STANDARD |
| LABELING; Labeling | SUPPL | 31 | AP | 2007-11-05 | STANDARD |
Submissions Property Types
| SUPPL | 3 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 21 | Null | 0 |
| SUPPL | 24 | Null | 0 |
| SUPPL | 28 | Null | 8 |
| SUPPL | 30 | Null | 0 |
CDER Filings
cder:Array
(
[0] => Array
(
[ApplNo] => 19510
[companyName] =>
[docInserts] => ["",""]
[products] => []
[labels] =>
[originalApprovals] => []
[supplements] =>
[actionDate] => 0000-00-00
)
)