cefprozil Oral Suspension
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Lupin Pharmaceuticals, Inc. (2011-04-01)
- Oldest Current Product
- 2005-12-01
- License(s)
- ANDA
- RxNORM
- ORAL SUSPENSION\CEFPROZIL
- FDAOB
- ORAL\FOR SUSPENSION\CEFPROZIL
- SPL Active
- ORAL\POWDER, FOR SUSPENSION\CEFPROZIL
- SPL Moiety
- ORAL\POWDER, FOR SUSPENSION\CEFPROZIL
ORAL\POWDER, FOR SUSPENSION\CEFPROZIL ANHYDROUS
product(s) by strength(s)
cefprozil 25 mg/ml oral suspension
generic product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 000931075 | ANDA | Teva Pharmaceuticals Usa Inc | 2006-03-04 | CEFPROZIL | ORAL | POWDER, FOR SUSPENSION | ANDA065236 | 6737ed97-9559-44c7-889b-6bc0e20eb36b |
| 2 | 007816202 | ANDA | Sandoz Inc | 2005-12-05 | CEFPROZIL | ORAL | POWDER, FOR SUSPENSION | ANDA065257 | a547cc0a-6af0-49c7-a5ea-c41684cc36ae |
| 3 | 167140396 | ANDA | Northstar Rx Llc | 2007-01-30 | CEFPROZIL | ORAL | POWDER, FOR SUSPENSION | ANDA065381 | 8e3943b5-8c30-4c81-bcfa-aeaaa1d75fb4 |
| 4 | 420430262 | ANDA | Orchidpharma Inc | 2015-08-19 | CEFPROZIL | ORAL | POWDER, FOR SUSPENSION | ANDA065284 | 9825b787-72de-4555-9907-3738bd761e57 |
| 5 | 572370034 | ANDA | Citron Pharma Llc | 2007-01-30 | CEFPROZIL | ORAL | POWDER, FOR SUSPENSION | ANDA065381 | d7fac9cc-30e1-4762-a01b-04f1bd3b2a56 |
| 6 | 658620099 | ANDA | Aurobindo Pharma Limited | 2007-01-30 | CEFPROZIL | ORAL | POWDER, FOR SUSPENSION | ANDA065381 | 97675251-70b8-43bc-93ea-f9ef6bb8cb68 |
| 7 | 672530233 | ANDA | Dava Pharmaceuticals, Inc. | 2014-08-01 | CEFPROZIL | ORAL | POWDER, FOR SUSPENSION | ANDA065257 | d2dbfc48-063b-41c0-864c-2c9426ba89c1 |
| 8 | 681800401 | ANDA | Lupin Pharmaceuticals, Inc. | 2005-12-01 | CEFPROZIL | ORAL | POWDER, FOR SUSPENSION | ANDA065261 | 3ec55c0a-1456-412e-972f-352b3135c8f2 |
cefprozil 50 mg/ml oral suspension
generic product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 000931076 | ANDA | Teva Pharmaceuticals Usa Inc | 2005-12-23 | CEFPROZIL | ORAL | POWDER, FOR SUSPENSION | ANDA065236 | 6737ed97-9559-44c7-889b-6bc0e20eb36b |
| 2 | 007816203 | ANDA | Sandoz Inc | 2005-12-05 | CEFPROZIL | ORAL | POWDER, FOR SUSPENSION | ANDA065257 | a547cc0a-6af0-49c7-a5ea-c41684cc36ae |
| 3 | 167140397 | ANDA | Northstar Rx Llc | 2007-01-30 | CEFPROZIL | ORAL | POWDER, FOR SUSPENSION | ANDA065381 | 8e3943b5-8c30-4c81-bcfa-aeaaa1d75fb4 |
| 4 | 420430263 | ANDA | Orchidpharma Inc | 2015-08-19 | CEFPROZIL | ORAL | POWDER, FOR SUSPENSION | ANDA065284 | 9825b787-72de-4555-9907-3738bd761e57 |
| 5 | 572370035 | ANDA | Citron Pharma Llc | 2007-01-30 | CEFPROZIL | ORAL | POWDER, FOR SUSPENSION | ANDA065381 | d7fac9cc-30e1-4762-a01b-04f1bd3b2a56 |
| 6 | 658620100 | ANDA | Aurobindo Pharma Limited | 2007-01-30 | CEFPROZIL | ORAL | POWDER, FOR SUSPENSION | ANDA065381 | 97675251-70b8-43bc-93ea-f9ef6bb8cb68 |
| 7 | 672530234 | ANDA | Dava Pharmaceuticals, Inc. | 2014-08-01 | CEFPROZIL | ORAL | POWDER, FOR SUSPENSION | ANDA065257 | d2dbfc48-063b-41c0-864c-2c9426ba89c1 |
relabeler product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | equivalent product | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 545695785 | ANDA | A-S Medication Solutions Llc | 2005-12-01 | CEFPROZIL | ORAL | POWDER, FOR SUSPENSION | 681800402 | ANDA065261 | 4d17e35a-0ca1-4a6b-8b69-ea8f0d62938f |
| 2 | 548685757 | ANDA | Physicians Total Care, Inc. | 2007-02-05 | CEFPROZIL | ORAL | POWDER, FOR SUSPENSION | 68180040203 | ANDA065261 | c6d3c1ff-d873-4903-befa-c0ba47034c6e |
application(s)
| # | id | title | deprecated | applicant | approved | approved drug |
|---|---|---|---|---|---|---|
| 1 | ANDA065202 | CEFPROZIL | True | RANBAXY LABORATORIES LTD | 2006-06-30 | ANDA065202_001, ANDA065202_002 |
| 2 | ANDA065236 | CEFPROZIL | TEVA PHARMACEUTICALS USA | 2005-12-08 | ANDA065236_001, ANDA065236_002 | |
| 3 | ANDA065257 | CEFPROZIL | SANDOZ INC | 2005-12-08 | ANDA065257_001, ANDA065257_002 | |
| 4 | ANDA065261 | CEFPROZIL | LUPIN LTD | 2005-12-19 | ANDA065261_001, ANDA065261_002 | |
| 5 | ANDA065284 | CEFPROZIL | ORCHID HEALTHCARE | 2005-12-30 | ANDA065284_001, ANDA065284_002 | |
| 6 | ANDA065351 | CEFPROZIL | APOTEX INC | 2012-02-29 | ANDA065351_001, ANDA065351_002 | |
| 7 | ANDA065381 | CEFPROZIL | AUROBINDO PHARMA LTD | 2007-01-30 | ANDA065381_001, ANDA065381_002 | |
| 8 | NDA050665 | CEFZIL | True | CORDEN PHARMA LATINA SPA | 1991-12-23 | NDA050665_001, NDA050665_002 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | route | dose form | rld | TE | approved | application |
|---|---|---|---|---|---|---|---|---|---|
| 1 | ANDA065202_001 | discontinued | CEFPROZIL (125MG/5ML) | ORAL | FOR SUSPENSION | False | 2006-06-30 | CEFPROZIL | |
| 2 | ANDA065202_002 | discontinued | CEFPROZIL (250MG/5ML) | ORAL | FOR SUSPENSION | False | 2006-06-30 | CEFPROZIL | |
| 3 | ANDA065236_001 | RX | CEFPROZIL (125MG/5ML) | ORAL | FOR SUSPENSION | False | AB | 2005-12-08 | CEFPROZIL |
| 4 | ANDA065236_002 | RX | CEFPROZIL (250MG/5ML) | ORAL | FOR SUSPENSION | False | AB | 2005-12-08 | CEFPROZIL |
| 5 | ANDA065257_001 | RX | CEFPROZIL (125MG/5ML) | ORAL | FOR SUSPENSION | False | AB | 2005-12-08 | CEFPROZIL |
| 6 | ANDA065257_002 | RX | CEFPROZIL (250MG/5ML) | ORAL | FOR SUSPENSION | False | AB | 2005-12-08 | CEFPROZIL |
| 7 | ANDA065261_001 | RX | CEFPROZIL (125MG/5ML) | ORAL | FOR SUSPENSION | False | AB | 2005-12-19 | CEFPROZIL |
| 8 | ANDA065261_002 | RX | CEFPROZIL (250MG/5ML) | ORAL | FOR SUSPENSION | True | AB | 2005-12-19 | CEFPROZIL |
| 9 | ANDA065284_001 | RX | CEFPROZIL (250MG/5ML) | ORAL | FOR SUSPENSION | False | AB | 2005-12-30 | CEFPROZIL |
| 10 | ANDA065284_002 | RX | CEFPROZIL (125MG/5ML) | ORAL | FOR SUSPENSION | False | AB | 2005-12-30 | CEFPROZIL |
| 11 | ANDA065351_001 | RX | CEFPROZIL (125MG/5ML) | ORAL | FOR SUSPENSION | False | AB | 2012-02-29 | CEFPROZIL |
| 12 | ANDA065351_002 | RX | CEFPROZIL (250MG/5ML) | ORAL | FOR SUSPENSION | False | AB | 2012-02-29 | CEFPROZIL |
| 13 | ANDA065381_001 | RX | CEFPROZIL (125MG/5ML) | ORAL | FOR SUSPENSION | False | AB | 2007-01-30 | CEFPROZIL |
| 14 | ANDA065381_002 | RX | CEFPROZIL (250MG/5ML) | ORAL | FOR SUSPENSION | False | AB | 2007-01-30 | CEFPROZIL |
| 15 | NDA050665_001 | discontinued | CEFPROZIL (125MG/5ML) | ORAL | FOR SUSPENSION | False | 1991-12-23 | CEFZIL | |
| 16 | NDA050665_002 | discontinued | CEFPROZIL (250MG/5ML) | ORAL | FOR SUSPENSION | False | 1991-12-23 | CEFZIL |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) | in other drug docs |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 3ec55c0a-1456-412e-972f-352b3135c8f2 (view SPL) | cefprozil for oral suspension usp 125 mg/5 mL and 250 mg/5 mL | prescription | Human Prescription | Lupin Pharmaceuticals, Inc. | 2011-04-01 | 2 | 681800401 | ||
| 2 | 4d17e35a-0ca1-4a6b-8b69-ea8f0d62938f (view SPL) | cefprozil for oral suspension usp 125 mg/5 mL and 250 mg/5 mL | prescription | Human Prescription | A-S Medication Solutions Llc | relabel | 2013-06-22 | 1 | 545695785 | |
| 3 | 6737ed97-9559-44c7-889b-6bc0e20eb36b (view SPL) | CEFPROZIL FOR ORAL SUSPENSION USP10751076Rx only | prescription | Human Prescription | Teva Pharmaceuticals Usa Inc | 2012-08-13 | 4 | 000931075, 000931076 | ||
| 4 | 8e3943b5-8c30-4c81-bcfa-aeaaa1d75fb4 (view SPL) | prescription | Human Prescription | Northstar Rx Llc | ANALYSIS, API MANUFACTURE, MANUFACTURE | 2013-01-09 | 1 | 167140396, 167140397 | ||
| 5 | 97675251-70b8-43bc-93ea-f9ef6bb8cb68 (view SPL) | prescription | Human Prescription | Aurobindo Pharma Limited | ANALYSIS, API MANUFACTURE, MANUFACTURE | 2013-07-05 | 6 | 658620099, 658620100 | ||
| 6 | 9825b787-72de-4555-9907-3738bd761e57 (view SPL) | CEFPROZIL FOR ORAL SUSPENSION, USP | prescription | Human Prescription | Orchidpharma Inc | analysis, label, manufacture, pack | 2015-08-24 | 1 | 420430262, 420430263 | |
| 7 | a547cc0a-6af0-49c7-a5ea-c41684cc36ae (view SPL) | CEFPROZIL TABLETS, USP 250 mg and 500 mg CEFPROZIL for ORAL SUSPENSION, USP 125 mg/5 mL and 250 mg/5 mL | prescription | Human Prescription | Sandoz Inc | 2015-05-15 | 11 | 007816202, 007816203, 007815043, 007815044 | cefprozil Oral Tablet | |
| 8 | c6d3c1ff-d873-4903-befa-c0ba47034c6e (view SPL) | prescription | Human Prescription | Physicians Total Care, Inc. | relabel | 2010-12-08 | 1 | 548685757 | ||
| 9 | d2dbfc48-063b-41c0-864c-2c9426ba89c1 (view SPL) | CEFPROZIL TABLETS, USP 250 mg and 500 mg CEFPROZIL for ORAL SUSPENSION, USP 125 mg/5 mL and 250 mg/5 mL | prescription | Human Prescription | Dava Pharmaceuticals, Inc. | 2014-03-06 | 10 | 672530233, 672530234, 672530231, 672530232 | cefprozil Oral Tablet | |
| 10 | d7fac9cc-30e1-4762-a01b-04f1bd3b2a56 (view SPL) | Cefprozil for Oral Suspension, USP Rx only | prescription | Human Prescription | Citron Pharma Llc | 2013-12-19 | 1 | 572370034, 572370035 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII