Cholestyramine Resin Oral Suspension
- Brand(s)
- Prevalite, Questran
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Upsher-Smith Laboratories, Inc. (2015-07-23)
- Oldest Current Product
- 1994-11-04
- License(s)
- ANDA
- RxNORM
- ORAL SUSPENSION\CHOLESTYRAMINE RESIN
- FDAOB
- ORAL\POWDER\CHOLESTYRAMINE
- SPL Active
- ORAL\POWDER, FOR SUSPENSION\CHOLESTYRAMINE
- SPL Moiety
- ORAL\POWDER, FOR SUSPENSION\CHOLESTYRAMINE
product(s) by strength(s)
cholestyramine resin 66.7 mg/ml oral suspension
generic product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 001850939 | ANDA | Eon Labs, Inc. | 1994-11-04 | CHOLESTYRAMINE | ORAL | POWDER, FOR SUSPENSION | ANDA074558 | a7dd335a-6413-446e-8098-d4f97e935986 | |
| 2 | 001850940 | ANDA | Eon Labs, Inc. | 1996-08-15 | CHOLESTYRAMINE | ORAL | POWDER, FOR SUSPENSION | ANDA074557 | 9269d9ba-d791-4865-8a39-abd1733d79bd | |
| 3 | 002450036 | Prevalite | ANDA | Upsher-Smith Laboratories, Inc. | 1996-02-01 | CHOLESTYRAMINE | ORAL | POWDER, FOR SUSPENSION | ANDA073263 | dd434ef8-8af3-434c-a0a0-9a0b18459ba0 |
| 4 | 002450536 | ANDA | Upsher-Smith Laboratories, Inc. | 2012-01-05 | CHOLESTYRAMINE | ORAL | POWDER, FOR SUSPENSION | ANDA074557 | aa1e8007-ec11-4a08-a343-b5b0645695a1 | |
| 5 | 498840465 | ANDA | Par Pharmaceutical Companies, Inc. | 2005-09-15 | CHOLESTYRAMINE | ORAL | POWDER, FOR SUSPENSION | ANDA077204 | b0c65058-22c3-4f57-9b61-9bc6fcd6e240 | |
| 6 | 498840466 | ANDA | Par Pharmaceutical Companies, Inc. | 2005-09-15 | CHOLESTYRAMINE | ORAL | POWDER, FOR SUSPENSION | ANDA077203 | b0c65058-22c3-4f57-9b61-9bc6fcd6e240 | |
| 7 | 498840936 | Questran | ANDA | Par Pharmaceutical Companies, Inc. | 2005-09-15 | CHOLESTYRAMINE | ORAL | POWDER, FOR SUSPENSION | ANDA077204 | 362ddd91-a63f-4ec6-841a-75785dd208c8 |
| 8 | 498840937 | Questran | ANDA | Par Pharmaceutical Companies, Inc. | 2003-07-24 | CHOLESTYRAMINE | ORAL | POWDER, FOR SUSPENSION | ANDA077203 | 362ddd91-a63f-4ec6-841a-75785dd208c8 |
relabeler product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | equivalent product | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 548684812 | ANDA | Physicians Total Care, Inc. | 2010-03-22 | CHOLESTYRAMINE | ORAL | POWDER, FOR SUSPENSION | 498840465 | ANDA077204 | 2835b6f5-93da-4554-9d84-79132fd928ee |
| 2 | 548685526 | ANDA | Physicians Total Care, Inc. | 2006-02-08 | CHOLESTYRAMINE | ORAL | POWDER, FOR SUSPENSION | 498840466 | ANDA077203 | 2835b6f5-93da-4554-9d84-79132fd928ee |
| 3 | 604290355 | ANDA | Golden State Medical Supply, Inc. | 2005-09-15 | CHOLESTYRAMINE | ORAL | POWDER, FOR SUSPENSION | 498840465 | ANDA077203 | 291701d5-1c9e-4629-a98f-26e035579a28 |
| 4 | 604290356 | ANDA | Golden State Medical Supply, Inc. | 2005-09-15 | CHOLESTYRAMINE | ORAL | POWDER, FOR SUSPENSION | 498840466 | ANDA077204 | 291701d5-1c9e-4629-a98f-26e035579a28 |
application(s)
| # | id | title | deprecated | applicant | approved | approved drug |
|---|---|---|---|---|---|---|
| 1 | ANDA073263 | PREVALITE | UPSHER SMITH LABORATORIES INC | 1996-02-22 | ANDA073263_001, ANDA073263_002 | |
| 2 | ANDA074347 | CHOLESTYRAMINE | True | TEVA PHARMACEUTICALS USA INC | 1998-05-28 | ANDA074347_001, ANDA074347_002 |
| 3 | ANDA074348 | CHOLESTYRAMINE LIGHT | True | TEVA PHARMACEUTICALS USA INC | 1998-05-28 | ANDA074348_001, ANDA074348_002 |
| 4 | ANDA074554 | CHOLESTYRAMINE | True | ANI PHARMACEUTICALS INC | 1996-10-02 | ANDA074554_001, ANDA074554_002 |
| 5 | ANDA074555 | CHOLESTYRAMINE LIGHT | True | TEVA PHARMACEUTICALS USA | 1998-09-30 | ANDA074555_001, ANDA074555_002 |
| 6 | ANDA074557 | CHOLESTYRAMINE | SANDOZ INC | 1996-08-15 | ANDA074557_001, ANDA074557_002 | |
| 7 | ANDA074558 | CHOLESTYRAMINE LIGHT | SANDOZ INC | 1996-08-15 | ANDA074558_001, ANDA074558_002 | |
| 8 | ANDA074561 | LOCHOLEST | True | SANDOZ INC | 1996-08-15 | ANDA074561_001, ANDA074561_002 |
| 9 | ANDA074562 | LOCHOLEST LIGHT | True | SANDOZ INC | 1996-08-15 | ANDA074562_001, ANDA074562_002 |
| 10 | ANDA074771 | CHOLESTYRAMINE | True | IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA | 1997-07-09 | ANDA074771_001, ANDA074771_002 |
| 11 | ANDA077203 | CHOLESTYRAMINE LIGHT | PAR PHARMACEUTICAL INC | 2005-08-26 | ANDA077203_001, ANDA077203_002 | |
| 12 | ANDA077204 | CHOLESTYRAMINE | PAR PHARMACEUTICAL INC | 2005-08-26 | ANDA077204_001, ANDA077204_002 | |
| 13 | NDA016640 | QUESTRAN | True | BRISTOL MYERS CO | NDA016640_001, NDA016640_003 | |
| 14 | NDA019669 | QUESTRAN LIGHT | True | BRISTOL MYERS CO | 1988-12-05 | NDA019669_001, NDA019669_003 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | route | dose form | rld | TE | approved | application |
|---|---|---|---|---|---|---|---|---|---|
| 1 | ANDA073263_001 | RX | CHOLESTYRAMINE (EQ 4GM RESIN/PACKET) | ORAL | POWDER | False | AB | 1996-02-22 | PREVALITE |
| 2 | ANDA073263_002 | RX | CHOLESTYRAMINE (EQ 4GM RESIN/SCOOPFUL) | ORAL | POWDER | False | AB | 1997-10-30 | PREVALITE |
| 3 | ANDA074347_001 | discontinued | CHOLESTYRAMINE (EQ 4GM RESIN/PACKET) | ORAL | POWDER | False | 1998-05-28 | CHOLESTYRAMINE | |
| 4 | ANDA074347_002 | discontinued | CHOLESTYRAMINE (EQ 4GM RESIN/SCOOPFUL) | ORAL | POWDER | False | 1998-05-28 | CHOLESTYRAMINE | |
| 5 | ANDA074348_001 | discontinued | CHOLESTYRAMINE (EQ 4GM RESIN/PACKET) | ORAL | POWDER | False | 1998-05-28 | CHOLESTYRAMINE LIGHT | |
| 6 | ANDA074348_002 | discontinued | CHOLESTYRAMINE (EQ 4GM RESIN/SCOOPFUL) | ORAL | POWDER | False | 1998-05-28 | CHOLESTYRAMINE LIGHT | |
| 7 | ANDA074554_001 | discontinued | CHOLESTYRAMINE (EQ 4GM RESIN/PACKET) | ORAL | POWDER | False | 1996-10-02 | CHOLESTYRAMINE | |
| 8 | ANDA074554_002 | discontinued | CHOLESTYRAMINE (EQ 4GM RESIN/SCOOPFUL) | ORAL | POWDER | False | 1996-10-02 | CHOLESTYRAMINE | |
| 9 | ANDA074555_001 | discontinued | CHOLESTYRAMINE (EQ 4GM RESIN/PACKET) | ORAL | POWDER | False | 1998-09-30 | CHOLESTYRAMINE LIGHT | |
| 10 | ANDA074555_002 | discontinued | CHOLESTYRAMINE (EQ 4GM RESIN/SCOOPFUL) | ORAL | POWDER | False | 1998-09-30 | CHOLESTYRAMINE LIGHT | |
| 11 | ANDA074557_001 | RX | CHOLESTYRAMINE (EQ 4GM RESIN/PACKET) | ORAL | POWDER | True | AB | 1996-08-15 | CHOLESTYRAMINE |
| 12 | ANDA074557_002 | RX | CHOLESTYRAMINE (EQ 4GM RESIN/SCOOPFUL) | ORAL | POWDER | False | AB | 1996-08-15 | CHOLESTYRAMINE |
| 13 | ANDA074558_001 | RX | CHOLESTYRAMINE (EQ 4GM RESIN/PACKET) | ORAL | POWDER | True | AB | 1996-08-15 | CHOLESTYRAMINE LIGHT |
| 14 | ANDA074558_002 | RX | CHOLESTYRAMINE (EQ 4GM RESIN/SCOOPFUL) | ORAL | POWDER | False | AB | 1996-08-15 | CHOLESTYRAMINE LIGHT |
| 15 | ANDA074561_001 | discontinued | CHOLESTYRAMINE (EQ 4GM RESIN/PACKET) | ORAL | POWDER | False | 1996-08-15 | LOCHOLEST | |
| 16 | ANDA074561_002 | discontinued | CHOLESTYRAMINE (EQ 4GM RESIN/SCOOPFUL) | ORAL | POWDER | False | 1996-08-15 | LOCHOLEST | |
| 17 | ANDA074562_001 | discontinued | CHOLESTYRAMINE (EQ 4GM RESIN/PACKET) | ORAL | POWDER | False | 1996-08-15 | LOCHOLEST LIGHT | |
| 18 | ANDA074562_002 | discontinued | CHOLESTYRAMINE (EQ 4GM RESIN/SCOOPFUL) | ORAL | POWDER | False | 1996-08-15 | LOCHOLEST LIGHT | |
| 19 | ANDA074771_001 | discontinued | CHOLESTYRAMINE (EQ 4GM RESIN/PACKET) | ORAL | POWDER | False | 1997-07-09 | CHOLESTYRAMINE | |
| 20 | ANDA074771_002 | discontinued | CHOLESTYRAMINE (EQ 4GM RESIN/SCOOPFUL) | ORAL | POWDER | False | 1997-07-09 | CHOLESTYRAMINE | |
| 21 | ANDA077203_001 | RX | CHOLESTYRAMINE (EQ 4GM RESIN/PACKET) | ORAL | POWDER | False | AB | 2005-08-26 | CHOLESTYRAMINE LIGHT |
| 22 | ANDA077203_002 | RX | CHOLESTYRAMINE (EQ 4GM RESIN/SCOOPFUL) | ORAL | POWDER | False | AB | 2005-08-26 | CHOLESTYRAMINE LIGHT |
| 23 | ANDA077204_001 | RX | CHOLESTYRAMINE (EQ 4GM RESIN/PACKET) | ORAL | POWDER | False | AB | 2005-08-26 | CHOLESTYRAMINE |
| 24 | ANDA077204_002 | RX | CHOLESTYRAMINE (EQ 4GM RESIN/SCOOPFUL) | ORAL | POWDER | False | AB | 2005-08-26 | CHOLESTYRAMINE |
| 25 | NDA016640_001 | discontinued | CHOLESTYRAMINE (EQ 4GM RESIN/PACKET) | ORAL | POWDER | False | QUESTRAN | ||
| 26 | NDA016640_003 | discontinued | CHOLESTYRAMINE (EQ 4GM RESIN/SCOOPFUL) | ORAL | POWDER | False | QUESTRAN | ||
| 27 | NDA019669_001 | discontinued | CHOLESTYRAMINE (EQ 4GM RESIN/PACKET) | ORAL | POWDER | False | 1988-12-05 | QUESTRAN LIGHT | |
| 28 | NDA019669_003 | discontinued | CHOLESTYRAMINE (EQ 4GM RESIN/SCOOPFUL) | ORAL | POWDER | False | 1988-12-05 | QUESTRAN LIGHT |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 2835b6f5-93da-4554-9d84-79132fd928ee (view SPL) | prescription | Human Prescription | Physicians Total Care, Inc. | relabel | 2010-04-28 | 1 | 548684812, 548685526 | |
| 2 | 291701d5-1c9e-4629-a98f-26e035579a28 (view SPL) | CHOLESTYRAMINE for ORAL SUSPENSION USP and CHOLESTYRAMINE for ORAL SUSPENSION USP, LIGHT | prescription | Human Prescription | Golden State Medical Supply, Inc. | RELABEL | 2012-01-09 | 1 | 604290355, 604290356 |
| 3 | 362ddd91-a63f-4ec6-841a-75785dd208c8 (view SPL) | prescription | Human Prescription | Par Pharmaceutical Companies, Inc. | MANUFACTURE | 2015-01-06 | 5 | 498840936, 498840937 | |
| 4 | 9269d9ba-d791-4865-8a39-abd1733d79bd (view SPL) | Cholestyramine for Oral Suspension USP | prescription | Human Prescription | Eon Labs, Inc. | 2014-10-13 | 5 | 001850940 | |
| 5 | a7dd335a-6413-446e-8098-d4f97e935986 (view SPL) | Cholestyramine for Oral Suspension USP Light | prescription | Human Prescription | Eon Labs, Inc. | 2014-10-10 | 5 | 001850939 | |
| 6 | aa1e8007-ec11-4a08-a343-b5b0645695a1 (view SPL) | Cholestyramine for Oral Suspension, USP | prescription | Human Prescription | Upsher-Smith Laboratories, Inc. | 2015-05-20 | 4 | 002450536 | |
| 7 | b0c65058-22c3-4f57-9b61-9bc6fcd6e240 (view SPL) | prescription | Human Prescription | Par Pharmaceutical Companies, Inc. | MANUFACTURE | 2014-12-18 | 7 | 498840465, 498840466 | |
| 8 | dd434ef8-8af3-434c-a0a0-9a0b18459ba0 (view SPL) | Prevalite (Cholestyramine for Oral Suspension, USP) | prescription | Human Prescription | Upsher-Smith Laboratories, Inc. | ANALYSIS, LABEL, MANUFACTURE, PACK | 2015-07-23 | 4 | 002450036 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII