Cefadroxil Oral Suspension
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Lupin Pharmaceuticals, Inc. (2014-03-07)
- Oldest Current Product
- 2005-08-30
- License(s)
- ANDA
- RxNORM
- ORAL SUSPENSION\CEFADROXIL
- FDAOB
- ORAL\FOR SUSPENSION\CEFADROXIL/CEFADROXIL HEMIHYDRATE
- SPL Active
- ORAL\POWDER, FOR SUSPENSION\CEFADROXIL
- SPL Moiety
- ORAL\POWDER, FOR SUSPENSION\CEFADROXIL
ORAL\POWDER, FOR SUSPENSION\CEFADROXIL ANHYDROUS
product(s) by strength(s)
cefadroxil 100 mg/ml oral suspension
generic product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 001439766 | ANDA | West-Ward Pharmaceutical Corp | 2012-11-28 | CEFADROXIL | ORAL | POWDER, FOR SUSPENSION | ANDA091036 | 1662f7df-ce96-4d24-ae32-9a7f8833311d |
| 2 | 167140390 | ANDA | Northstar Rx Llc | 2013-04-25 | CEFADROXIL | ORAL | POWDER, FOR SUSPENSION | ANDA065349 | 30bb3686-87b4-4676-9ff5-e20deb8bff9d |
| 3 | 572370098 | ANDA | Citron Pharma Llc | 2013-04-25 | CEFADROXIL | ORAL | POWDER, FOR SUSPENSION | ANDA065349 | 6e4111d3-f11b-403c-b340-b216022709df |
| 4 | 633040974 | ANDA | Rnabaxy Pharmaceuticals Inc. | 2005-08-30 | CEFADROXIL | ORAL | POWDER, FOR SUSPENSION | ANDA065115 | 5fc4f89c-cf94-4e7a-bf31-d3d86a242efa |
| 5 | 658620084 | ANDA | Aurobindo Pharma Limited | 2013-04-25 | CEFADROXIL | ORAL | POWDER, FOR SUSPENSION | ANDA065349 | 776a8dbc-e68e-4732-acf4-0133dca0f54c |
invalid application product(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 000934181 | ANDA | Teva Pharmaceuticals Usa Inc | 2010-02-02 | CEFADROXIL | ORAL | POWDER, FOR SUSPENSION | ANDA065278 | 9d421f13-579c-4096-aa4e-1f931cd1d95c |
relabeler product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | equivalent product | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 548685694 | ANDA | Physicians Total Care, Inc. | 2007-05-16 | CEFADROXIL | ORAL | POWDER, FOR SUSPENSION | 633040974 | ANDA065115 | 4306730b-e894-45ca-b4e9-3fe7f65b7b1d |
cefadroxil 25 mg/ml oral suspension
generic product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 633040972 | ANDA | Rnabaxy Pharmaceuticals Inc. | 2005-08-30 | CEFADROXIL | ORAL | POWDER, FOR SUSPENSION | ANDA065115 | 5fc4f89c-cf94-4e7a-bf31-d3d86a242efa |
cefadroxil 50 mg/ml oral suspension
generic product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 001439767 | ANDA | West-Ward Pharmaceutical Corp | 2012-11-28 | CEFADROXIL | ORAL | POWDER, FOR SUSPENSION | ANDA091036 | 1662f7df-ce96-4d24-ae32-9a7f8833311d |
| 2 | 167140389 | ANDA | Northstar Rx Llc | 2013-04-25 | CEFADROXIL | ORAL | POWDER, FOR SUSPENSION | ANDA065349 | 30bb3686-87b4-4676-9ff5-e20deb8bff9d |
| 3 | 572370097 | ANDA | Citron Pharma Llc | 2013-04-25 | CEFADROXIL | ORAL | POWDER, FOR SUSPENSION | ANDA065349 | 6e4111d3-f11b-403c-b340-b216022709df |
| 4 | 633040973 | ANDA | Rnabaxy Pharmaceuticals Inc. | 2005-08-30 | CEFADROXIL | ORAL | POWDER, FOR SUSPENSION | ANDA065115 | 5fc4f89c-cf94-4e7a-bf31-d3d86a242efa |
| 5 | 658620083 | ANDA | Aurobindo Pharma Limited | 2013-04-25 | CEFADROXIL | ORAL | POWDER, FOR SUSPENSION | ANDA065349 | 776a8dbc-e68e-4732-acf4-0133dca0f54c |
| 6 | 681800181 | ANDA | Lupin Pharmaceuticals, Inc. | 2008-04-23 | CEFADROXIL | ORAL | POWDER, FOR SUSPENSION | ANDA065396 | 27009a05-4d2b-4618-be76-39f348240eda |
invalid application product(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 000934180 | ANDA | Teva Pharmaceuticals Usa Inc | 2010-02-02 | CEFADROXIL | ORAL | POWDER, FOR SUSPENSION | ANDA065278 | 9d421f13-579c-4096-aa4e-1f931cd1d95c |
relabeler product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | equivalent product | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 548685693 | ANDA | Physicians Total Care, Inc. | 2006-10-19 | CEFADROXIL | ORAL | POWDER, FOR SUSPENSION | 633040973 | ANDA065115 | 4306730b-e894-45ca-b4e9-3fe7f65b7b1d |
application(s)
| # | id | title | deprecated | applicant | approved | approved drug |
|---|---|---|---|---|---|---|
| 1 | ANDA062334 | CEFADROXIL | True | APOTHECON INC DIV BRISTOL MYERS SQUIBB | ANDA062334_001, ANDA062334_002, ANDA062334_003 | |
| 2 | ANDA062376 | ULTRACEF | True | BRISTOL LABORATORIES INC DIV BRISTOL MYERS CO | 1982-03-16 | ANDA062376_001, ANDA062376_002, ANDA062376_003 |
| 3 | ANDA062698 | CEFADROXIL | True | ANI PHARMACEUTICALS INC | 1989-03-01 | ANDA062698_001, ANDA062698_002, ANDA062698_003 |
| 4 | ANDA065115 | CEFADROXIL | SUN PHARMACEUTICAL INDUSTRIES LTD | 2003-03-26 | ANDA065115_001, ANDA065115_002, ANDA065115_003 | |
| 5 | ANDA065278 | CEFADROXIL | True | ANI PHARMACEUTICALS INC | 2006-01-20 | ANDA065278_001, ANDA065278_002 |
| 6 | ANDA065307 | CEFADROXIL | ORCHID HEALTHCARE | 2006-10-16 | ANDA065307_002, ANDA065307_003 | |
| 7 | ANDA065349 | CEFADROXIL | AUROBINDO PHARMA LTD | 2013-04-25 | ANDA065349_001, ANDA065349_002 | |
| 8 | ANDA065396 | CEFADROXIL | LUPIN LTD | 2008-02-21 | ANDA065396_001, ANDA065396_002 | |
| 9 | ANDA091036 | CEFADROXIL | HIKMA PHARMACEUTICALS | 2012-11-28 | ANDA091036_001, ANDA091036_002 | |
| 10 | NDA050527 | DURICEF | True | WARNER CHILCOTT INC | NDA050527_001, NDA050527_002, NDA050527_003 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | route | dose form | rld | TE | approved | application |
|---|---|---|---|---|---|---|---|---|---|
| 1 | ANDA062334_001 | discontinued | CEFADROXIL/CEFADROXIL HEMIHYDRATE (EQ 125MG BASE/5ML) | ORAL | FOR SUSPENSION | False | CEFADROXIL | ||
| 2 | ANDA062334_002 | discontinued | CEFADROXIL/CEFADROXIL HEMIHYDRATE (EQ 250MG BASE/5ML) | ORAL | FOR SUSPENSION | False | CEFADROXIL | ||
| 3 | ANDA062334_003 | discontinued | CEFADROXIL/CEFADROXIL HEMIHYDRATE (EQ 500MG BASE/5ML) | ORAL | FOR SUSPENSION | False | CEFADROXIL | ||
| 4 | ANDA062376_001 | discontinued | CEFADROXIL/CEFADROXIL HEMIHYDRATE (EQ 125MG BASE/5ML) | ORAL | FOR SUSPENSION | False | 1982-03-16 | ULTRACEF | |
| 5 | ANDA062376_002 | discontinued | CEFADROXIL/CEFADROXIL HEMIHYDRATE (EQ 250MG BASE/5ML) | ORAL | FOR SUSPENSION | False | 1982-03-16 | ULTRACEF | |
| 6 | ANDA062376_003 | discontinued | CEFADROXIL/CEFADROXIL HEMIHYDRATE (EQ 500MG BASE/5ML) | ORAL | FOR SUSPENSION | False | 1982-03-16 | ULTRACEF | |
| 7 | ANDA062698_001 | discontinued | CEFADROXIL/CEFADROXIL HEMIHYDRATE (EQ 125MG BASE/5ML) | ORAL | FOR SUSPENSION | False | 1989-03-01 | CEFADROXIL | |
| 8 | ANDA062698_002 | discontinued | CEFADROXIL/CEFADROXIL HEMIHYDRATE (EQ 250MG BASE/5ML) | ORAL | FOR SUSPENSION | False | 1989-03-01 | CEFADROXIL | |
| 9 | ANDA062698_003 | discontinued | CEFADROXIL/CEFADROXIL HEMIHYDRATE (EQ 500MG BASE/5ML) | ORAL | FOR SUSPENSION | False | 1989-03-01 | CEFADROXIL | |
| 10 | ANDA065115_001 | RX | CEFADROXIL/CEFADROXIL HEMIHYDRATE (EQ 125MG BASE/5ML) | ORAL | FOR SUSPENSION | False | 2003-03-26 | CEFADROXIL | |
| 11 | ANDA065115_002 | RX | CEFADROXIL/CEFADROXIL HEMIHYDRATE (EQ 250MG BASE/5ML) | ORAL | FOR SUSPENSION | False | AB | 2003-03-26 | CEFADROXIL |
| 12 | ANDA065115_003 | RX | CEFADROXIL/CEFADROXIL HEMIHYDRATE (EQ 500MG BASE/5ML) | ORAL | FOR SUSPENSION | False | AB | 2003-03-26 | CEFADROXIL |
| 13 | ANDA065278_001 | discontinued | CEFADROXIL/CEFADROXIL HEMIHYDRATE (EQ 250MG BASE/5ML) | ORAL | FOR SUSPENSION | False | 2006-01-20 | CEFADROXIL | |
| 14 | ANDA065278_002 | discontinued | CEFADROXIL/CEFADROXIL HEMIHYDRATE (EQ 500MG BASE/5ML) | ORAL | FOR SUSPENSION | False | 2006-01-20 | CEFADROXIL | |
| 15 | ANDA065307_002 | RX | CEFADROXIL/CEFADROXIL HEMIHYDRATE (EQ 250MG BASE/5ML) | ORAL | FOR SUSPENSION | False | AB | 2006-10-16 | CEFADROXIL |
| 16 | ANDA065307_003 | RX | CEFADROXIL/CEFADROXIL HEMIHYDRATE (EQ 500MG BASE/5ML) | ORAL | FOR SUSPENSION | False | AB | 2006-10-16 | CEFADROXIL |
| 17 | ANDA065349_001 | RX | CEFADROXIL/CEFADROXIL HEMIHYDRATE (EQ 250MG BASE/5ML) | ORAL | FOR SUSPENSION | False | AB | 2013-04-25 | CEFADROXIL |
| 18 | ANDA065349_002 | RX | CEFADROXIL/CEFADROXIL HEMIHYDRATE (EQ 500MG BASE/5ML) | ORAL | FOR SUSPENSION | False | AB | 2013-04-25 | CEFADROXIL |
| 19 | ANDA065396_001 | RX | CEFADROXIL/CEFADROXIL HEMIHYDRATE (EQ 250MG BASE/5ML) | ORAL | FOR SUSPENSION | False | AB | 2008-02-21 | CEFADROXIL |
| 20 | ANDA065396_002 | RX | CEFADROXIL/CEFADROXIL HEMIHYDRATE (EQ 500MG BASE/5ML) | ORAL | FOR SUSPENSION | True | AB | 2008-02-21 | CEFADROXIL |
| 21 | ANDA091036_001 | RX | CEFADROXIL/CEFADROXIL HEMIHYDRATE (EQ 250MG BASE/5ML) | ORAL | FOR SUSPENSION | False | AB | 2012-11-28 | CEFADROXIL |
| 22 | ANDA091036_002 | RX | CEFADROXIL/CEFADROXIL HEMIHYDRATE (EQ 500MG BASE/5ML) | ORAL | FOR SUSPENSION | False | AB | 2012-11-28 | CEFADROXIL |
| 23 | NDA050527_001 | discontinued | CEFADROXIL/CEFADROXIL HEMIHYDRATE (EQ 500MG BASE/5ML) | ORAL | FOR SUSPENSION | False | DURICEF | ||
| 24 | NDA050527_002 | discontinued | CEFADROXIL/CEFADROXIL HEMIHYDRATE (EQ 125MG BASE/5ML) | ORAL | FOR SUSPENSION | False | DURICEF | ||
| 25 | NDA050527_003 | discontinued | CEFADROXIL/CEFADROXIL HEMIHYDRATE (EQ 250MG BASE/5ML) | ORAL | FOR SUSPENSION | False | DURICEF |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 1662f7df-ce96-4d24-ae32-9a7f8833311d (view SPL) | CEFADROXIL for Oral suspension, USP 250 mg/5 mL and 500mg/5 mL Rev. 03/15 Rx only | prescription | Human Prescription | West-Ward Pharmaceutical Corp | 2015-03-01 | 3 | 001439766, 001439767 | |
| 2 | 27009a05-4d2b-4618-be76-39f348240eda (view SPL) | Cefadroxil for Oral Suspension USP, 250 mg/5 mL and 500 mg/5 mL | prescription | Human Prescription | Lupin Pharmaceuticals, Inc. | 2014-03-07 | 3 | 681800181 | |
| 3 | 30bb3686-87b4-4676-9ff5-e20deb8bff9d (view SPL) | Cefadroxil for Oral Suspension, USPRx only | prescription | Human Prescription | Northstar Rx Llc | ANALYSIS, API MANUFACTURE, MANUFACTURE | 2014-03-26 | 2 | 167140389, 167140390 |
| 4 | 4306730b-e894-45ca-b4e9-3fe7f65b7b1d (view SPL) | prescription | Human Prescription | Physicians Total Care, Inc. | relabel | 2010-05-11 | 1 | 548685693, 548685694 | |
| 5 | 5fc4f89c-cf94-4e7a-bf31-d3d86a242efa (view SPL) | CEFADROXIL FOR ORAL SUSPENSION, USPRx only | prescription | Human Prescription | Rnabaxy Pharmaceuticals Inc. | manufacture | 2013-08-14 | 2 | 633040972, 633040973, 633040974 |
| 6 | 6e4111d3-f11b-403c-b340-b216022709df (view SPL) | Cefadroxil for Oral Suspension, USPRx only | prescription | Human Prescription | Citron Pharma Llc | ANALYSIS, API MANUFACTURE, MANUFACTURE | 2014-09-04 | 1 | 572370097, 572370098 |
| 7 | 776a8dbc-e68e-4732-acf4-0133dca0f54c (view SPL) | Cefadroxil for Oral Suspension, USPRx only | prescription | Human Prescription | Aurobindo Pharma Limited | ANALYSIS, API MANUFACTURE, MANUFACTURE | 2014-02-27 | 2 | 658620083, 658620084 |
| 8 | 9d421f13-579c-4096-aa4e-1f931cd1d95c (view SPL) | CEFADROXIL FOR ORAL SUSPENSION USP41804181 | prescription | Human Prescription | Teva Pharmaceuticals Usa Inc | 2010-02-02 | 2 | 000934180, 000934181 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII