Cefaclor Oral Suspension
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Fsc Laboratories, Inc (2015-10-27)
- Oldest Current Product
- 1997-10-02
- License(s)
- ANDA
- RxNORM
- ORAL SUSPENSION\CEFACLOR
- FDAOB
- ORAL\FOR SUSPENSION\CEFACLOR
- SPL Active
- ORAL\FOR SUSPENSION\CEFACLOR
ORAL\SUSPENSION\CEFACLOR - SPL Moiety
- ORAL\FOR SUSPENSION\CEFACLOR ANHYDROUS
ORAL\SUSPENSION\CEFACLOR
ORAL\SUSPENSION\CEFACLOR ANHYDROUS
product(s) by strength(s)
cefaclor 25 mg/ml oral suspension
generic product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 135510125 | ANDA | Fsc Laboratories, Inc | 2015-10-26 | CEFACLOR | ORAL | FOR SUSPENSION | ANDA065412 | a619cf07-deb9-474d-bdb9-f662909540d4 |
| 2 | 165710070 | ANDA | Pack Pharmaceuticals Llc | 2012-10-25 | CEFACLOR | ORAL | SUSPENSION | ANDA065412 | ac5e34a9-994b-4611-aa41-3d1ed58a91c0 |
| 3 | 614420173 | ANDA | Carlsbad Technology, Inc. | 2012-03-27 | CEFACLOR | ORAL | SUSPENSION | ANDA065412 | 9f919252-7a87-4386-a64c-5d8213f7e881 |
cefaclor 37.4 mg/ml oral suspension
generic product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 614420174 | ANDA | Carlsbad Technology, Inc. | 2012-03-27 | CEFACLOR | ORAL | SUSPENSION | ANDA065412 | 9f919252-7a87-4386-a64c-5d8213f7e881 |
cefaclor 50 mg/ml oral suspension
generic product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 135510250 | ANDA | Fsc Laboratories, Inc | 2015-10-26 | CEFACLOR | ORAL | FOR SUSPENSION | ANDA065412 | a619cf07-deb9-474d-bdb9-f662909540d4 |
| 2 | 165710071 | ANDA | Pack Pharmaceuticals Llc | 2012-10-31 | CEFACLOR | ORAL | SUSPENSION | ANDA065412 | ac5e34a9-994b-4611-aa41-3d1ed58a91c0 |
| 3 | 614420175 | ANDA | Carlsbad Technology, Inc. | 2012-03-27 | CEFACLOR | ORAL | SUSPENSION | ANDA065412 | 9f919252-7a87-4386-a64c-5d8213f7e881 |
invalid application product(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | equivalent product | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 216950782 | ANDA | Rebel Distributors Corp | 1997-10-02 | CEFACLOR | ORAL | SUSPENSION | 633040956 | ANDA064164 | 9e8890f0-e04a-4555-ac8d-d1b792a5c276 |
cefaclor 75 mg/ml oral suspension
generic product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 135510375 | ANDA | Fsc Laboratories, Inc | 2015-10-26 | CEFACLOR | ORAL | FOR SUSPENSION | ANDA065412 | a619cf07-deb9-474d-bdb9-f662909540d4 |
| 2 | 165710072 | ANDA | Pack Pharmaceuticals Llc | 2012-10-31 | CEFACLOR | ORAL | SUSPENSION | ANDA065412 | ac5e34a9-994b-4611-aa41-3d1ed58a91c0 |
| 3 | 614420176 | ANDA | Carlsbad Technology, Inc. | 2012-03-27 | CEFACLOR | ORAL | SUSPENSION | ANDA065412 | 9f919252-7a87-4386-a64c-5d8213f7e881 |
application(s)
| # | id | title | deprecated | applicant | approved | approved drug |
|---|---|---|---|---|---|---|
| 1 | ANDA062206 | CEFACLOR | True | FACTA FARMACEUTICI SPA | ANDA062206_001, ANDA062206_002, ANDA062206_003, ANDA062206_004 | |
| 2 | ANDA064070 | CEFACLOR | True | IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA | 1995-04-28 | ANDA064070_001 |
| 3 | ANDA064085 | CEFACLOR | True | IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA | 1995-04-28 | ANDA064085_001 |
| 4 | ANDA064086 | CEFACLOR | True | IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA | 1995-04-28 | ANDA064086_001 |
| 5 | ANDA064087 | CEFACLOR | True | IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA | 1995-04-28 | ANDA064087_001 |
| 6 | ANDA064110 | CEFACLOR | True | DAVA PHARMACEUTICALS INC | 1995-04-28 | ANDA064110_001 |
| 7 | ANDA064114 | CEFACLOR | True | DAVA PHARMACEUTICALS INC | 1995-04-28 | ANDA064114_001 |
| 8 | ANDA064115 | CEFACLOR | True | DAVA PHARMACEUTICALS INC | 1995-04-28 | ANDA064115_001 |
| 9 | ANDA064116 | CEFACLOR | True | DAVA PHARMACEUTICALS INC | 1995-04-28 | ANDA064116_001 |
| 10 | ANDA064155 | CEFACLOR | True | RANBAXY PHARMACEUTICALS INC | 1997-10-02 | ANDA064155_001 |
| 11 | ANDA064164 | CEFACLOR | True | RANBAXY PHARMACEUTICALS INC | 1997-10-02 | ANDA064164_001 |
| 12 | ANDA064165 | CEFACLOR | True | RANBAXY PHARMACEUTICALS INC | 1997-10-02 | ANDA064165_001 |
| 13 | ANDA064166 | CEFACLOR | True | RANBAXY PHARMACEUTICALS INC | 1997-10-02 | ANDA064166_001 |
| 14 | ANDA064204 | CEFACLOR | True | WATSON LABORATORIES INC | 1998-02-18 | ANDA064204_001 |
| 15 | ANDA064205 | CEFACLOR | True | WATSON LABORATORIES INC | 1998-02-18 | ANDA064205_001 |
| 16 | ANDA064206 | CEFACLOR | True | WATSON LABORATORIES INC | 1998-02-18 | ANDA064206_001 |
| 17 | ANDA064207 | CEFACLOR | True | WATSON LABORATORIES INC | 1998-02-18 | ANDA064207_001 |
| 18 | ANDA065412 | CEFACLOR | YUNG SHIN PHARMACEUTICAL INDUSTRIAL CO LTD | 2012-02-17 | ANDA065412_001, ANDA065412_002, ANDA065412_003, ANDA065412_004 | |
| 19 | NDA050522 | CECLOR | True | ELI LILLY AND CO | NDA050522_001, NDA050522_002 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | route | dose form | rld | TE | approved | application |
|---|---|---|---|---|---|---|---|---|---|
| 1 | ANDA062206_001 | discontinued | CEFACLOR (EQ 125MG BASE/5ML) | ORAL | FOR SUSPENSION | False | CEFACLOR | ||
| 2 | ANDA062206_002 | discontinued | CEFACLOR (EQ 250MG BASE/5ML) | ORAL | FOR SUSPENSION | False | CEFACLOR | ||
| 3 | ANDA062206_003 | discontinued | CEFACLOR (EQ 187MG BASE/5ML) | ORAL | FOR SUSPENSION | False | 1988-04-20 | CEFACLOR | |
| 4 | ANDA062206_004 | discontinued | CEFACLOR (EQ 375MG BASE/5ML) | ORAL | FOR SUSPENSION | False | 1988-04-20 | CEFACLOR | |
| 5 | ANDA064070_001 | discontinued | CEFACLOR (EQ 375MG BASE/5ML) | ORAL | FOR SUSPENSION | False | 1995-04-28 | CEFACLOR | |
| 6 | ANDA064085_001 | discontinued | CEFACLOR (EQ 250MG BASE/5ML) | ORAL | FOR SUSPENSION | False | 1995-04-28 | CEFACLOR | |
| 7 | ANDA064086_001 | discontinued | CEFACLOR (EQ 187MG BASE/5ML) | ORAL | FOR SUSPENSION | False | 1995-04-28 | CEFACLOR | |
| 8 | ANDA064087_001 | discontinued | CEFACLOR (EQ 125MG BASE/5ML) | ORAL | FOR SUSPENSION | False | 1995-04-28 | CEFACLOR | |
| 9 | ANDA064110_001 | discontinued | CEFACLOR (EQ 375MG BASE/5ML) | ORAL | FOR SUSPENSION | False | 1995-04-28 | CEFACLOR | |
| 10 | ANDA064114_001 | discontinued | CEFACLOR (EQ 125MG BASE/5ML) | ORAL | FOR SUSPENSION | False | 1995-04-28 | CEFACLOR | |
| 11 | ANDA064115_001 | discontinued | CEFACLOR (EQ 187MG BASE/5ML) | ORAL | FOR SUSPENSION | False | 1995-04-28 | CEFACLOR | |
| 12 | ANDA064116_001 | discontinued | CEFACLOR (EQ 250MG BASE/5ML) | ORAL | FOR SUSPENSION | False | 1995-04-28 | CEFACLOR | |
| 13 | ANDA064155_001 | discontinued | CEFACLOR (EQ 375MG BASE/5ML) | ORAL | FOR SUSPENSION | False | 1997-10-02 | CEFACLOR | |
| 14 | ANDA064164_001 | discontinued | CEFACLOR (EQ 250MG BASE/5ML) | ORAL | FOR SUSPENSION | False | 1997-10-02 | CEFACLOR | |
| 15 | ANDA064165_001 | discontinued | CEFACLOR (EQ 187MG BASE/5ML) | ORAL | FOR SUSPENSION | False | 1997-10-02 | CEFACLOR | |
| 16 | ANDA064166_001 | discontinued | CEFACLOR (EQ 125MG BASE/5ML) | ORAL | FOR SUSPENSION | False | 1997-10-02 | CEFACLOR | |
| 17 | ANDA064204_001 | discontinued | CEFACLOR (EQ 125MG BASE/5ML) | ORAL | FOR SUSPENSION | False | 1998-02-18 | CEFACLOR | |
| 18 | ANDA064205_001 | discontinued | CEFACLOR (EQ 187MG BASE/5ML) | ORAL | FOR SUSPENSION | False | 1998-02-18 | CEFACLOR | |
| 19 | ANDA064206_001 | discontinued | CEFACLOR (EQ 250MG BASE/5ML) | ORAL | FOR SUSPENSION | False | 1998-02-18 | CEFACLOR | |
| 20 | ANDA064207_001 | discontinued | CEFACLOR (EQ 375MG BASE/5ML) | ORAL | FOR SUSPENSION | False | 1998-02-18 | CEFACLOR | |
| 21 | ANDA065412_001 | RX | CEFACLOR (EQ 125MG BASE/5ML) | ORAL | FOR SUSPENSION | False | AB | 2012-02-17 | CEFACLOR |
| 22 | ANDA065412_002 | RX | CEFACLOR (EQ 187MG BASE/5ML) | ORAL | FOR SUSPENSION | False | AB | 2012-02-17 | CEFACLOR |
| 23 | ANDA065412_003 | RX | CEFACLOR (EQ 250MG BASE/5ML) | ORAL | FOR SUSPENSION | False | AB | 2012-02-17 | CEFACLOR |
| 24 | ANDA065412_004 | RX | CEFACLOR (EQ 375MG BASE/5ML) | ORAL | FOR SUSPENSION | True | AB | 2012-02-17 | CEFACLOR |
| 25 | NDA050522_001 | discontinued | CEFACLOR (EQ 125MG BASE/5ML) | ORAL | FOR SUSPENSION | False | CECLOR | ||
| 26 | NDA050522_002 | discontinued | CEFACLOR (EQ 250MG BASE/5ML) | ORAL | FOR SUSPENSION | False | CECLOR |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 9e8890f0-e04a-4555-ac8d-d1b792a5c276 (view SPL) | CEFACLOR CAPSULES USP AND CEFACLOR FOR ORAL SUSPENSION USPRx only | prescription | Human Prescription | Rebel Distributors Corp | RELABEL, REPACK | 2011-07-20 | 1 | 216950782 |
| 2 | 9f919252-7a87-4386-a64c-5d8213f7e881 (view SPL) | Cefaclor for Oral Suspension, USP | prescription | Human Prescription | Carlsbad Technology, Inc. | LABEL, MANUFACTURE, PACK | 2015-09-09 | 3 | 614420173, 614420174, 614420175, 614420176 |
| 3 | a619cf07-deb9-474d-bdb9-f662909540d4 (view SPL) | Cefaclor for Oral Suspension, USP | prescription | Human Prescription | Fsc Laboratories, Inc | 2015-10-27 | 1 | 135510125, 135510250, 135510375 | |
| 4 | ac5e34a9-994b-4611-aa41-3d1ed58a91c0 (view SPL) | Cefaclor for Oral Suspension, USP | prescription | Human Prescription | Pack Pharmaceuticals Llc | MANUFACTURE | 2012-10-25 | 2 | 165710070, 165710071, 165710072 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII