Flavoxate Oral Tablet
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Paddock Laboratories, Llc (2014-07-24)
- Oldest Current Product
- 2003-08-28
- License(s)
- ANDA
- RxNORM
- ORAL TABLET\FLAVOXATE
- FDAOB
- ORAL\TABLET\FLAVOXATE HYDROCHLORIDE
- SPL Active
- ORAL\TABLET, FILM COATED\FLAVOXATE HYDROCHLORIDE
ORAL\TABLET\FLAVOXATE HYDROCHLORIDE - SPL Moiety
- ORAL\TABLET, FILM COATED\FLAVOXATE
ORAL\TABLET\FLAVOXATE
product(s) by strength(s)
flavoxate hydrochloride 100 mg oral tablet
generic product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 001151811 | ANDA | Global Pharmaceuticals | 2003-08-28 | FLAVOXATE HYDROCHLORIDE | ORAL | TABLET, FILM COATED | ANDA076234 | 7a60170f-37d1-429f-9726-b4ae27015ddf |
| 2 | 005740115 | ANDA | Paddock Laboratories, Llc | 2004-12-22 | FLAVOXATE HYDROCHLORIDE | ORAL | TABLET, FILM COATED | ANDA076831 | a9c44c4b-5b3c-45bf-9bc9-ce858e3d06c5 |
| 3 | 428060058 | ANDA | Epic Pharma, Llc | 2011-02-21 | FLAVOXATE HYDROCHLORIDE | ORAL | TABLET | ANDA076835 | b4260d7e-2ab3-49f6-aa57-bae19a23d82a |
| 4 | 512240154 | ANDA | Tagi Pharma, Inc. | 2011-03-25 | FLAVOXATE HYDROCHLORIDE | ORAL | TABLET, FILM COATED | ANDA076835 | 5cc7ad48-0918-444d-a97e-64c43852f3a6 |
relabeler product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | equivalent product | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 502680324 | ANDA | Avpak | 2012-11-30 | FLAVOXATE HYDROCHLORIDE | ORAL | TABLET | 428060058 | ANDA076835 | 9422e67e-d64c-3ba1-b2b9-ca9d3eeda743 |
| 2 | 548686326 | ANDA | Physicians Total Care, Inc. | 2012-01-04 | FLAVOXATE HYDROCHLORIDE | ORAL | TABLET, FILM COATED | 512240154 | ANDA076835 | e05f4892-0be8-4178-a274-3289edca0137 |
| 3 | 604290290 | ANDA | Golden State Medical Supply, Inc. | 2011-02-21 | FLAVOXATE HYDROCHLORIDE | ORAL | TABLET | 428060058 | ANDA076835 | 22a99f74-2718-48b3-b686-caf102d3071c |
| 4 | 681513826 | ANDA | Carilion Materials Management | 2004-12-22 | FLAVOXATE HYDROCHLORIDE | ORAL | TABLET, FILM COATED | 005740115 | ANDA076831 | 4c4470d2-4e62-4cce-af3c-113b6be7d986 |
application(s)
| # | id | title | deprecated | applicant | approved | approved drug |
|---|---|---|---|---|---|---|
| 1 | ANDA076234 | FLAVOXATE HYDROCHLORIDE | IMPAX PHARMACEUTICALS | 2003-08-28 | ANDA076234_001 | |
| 2 | ANDA076831 | FLAVOXATE HYDROCHLORIDE | PADDOCK LABORATORIES LLC | 2004-12-16 | ANDA076831_001 | |
| 3 | ANDA076835 | FLAVOXATE HYDROCHLORIDE | EPIC PHARMA LLC | 2005-11-30 | ANDA076835_001 | |
| 4 | NDA016769 | URISPAS | True | ORTHO MCNEIL JANSSEN PHARMACEUTICALS INC | NDA016769_001 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | route | dose form | rld | TE | approved | application |
|---|---|---|---|---|---|---|---|---|---|
| 1 | ANDA076234_001 | RX | FLAVOXATE HYDROCHLORIDE (100MG) | ORAL | TABLET | False | AB | 2003-08-28 | FLAVOXATE HYDROCHLORIDE |
| 2 | ANDA076831_001 | RX | FLAVOXATE HYDROCHLORIDE (100MG) | ORAL | TABLET | True | AB | 2004-12-16 | FLAVOXATE HYDROCHLORIDE |
| 3 | ANDA076835_001 | RX | FLAVOXATE HYDROCHLORIDE (100MG) | ORAL | TABLET | False | AB | 2005-11-30 | FLAVOXATE HYDROCHLORIDE |
| 4 | NDA016769_001 | discontinued | FLAVOXATE HYDROCHLORIDE (100MG) | ORAL | TABLET | False | URISPAS |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 22a99f74-2718-48b3-b686-caf102d3071c (view SPL) | Flavoxate Hydrochloride Tablets 100 mg, Film-CoatedRx only | prescription | Human Prescription | Golden State Medical Supply, Inc. | RELABEL, REPACK | 2011-07-01 | 1 | 604290290 |
| 2 | 4c4470d2-4e62-4cce-af3c-113b6be7d986 (view SPL) | Flavoxate HCl Tablets 100 mg | prescription | Human Prescription | Carilion Materials Management | REPACK | 2014-07-24 | 2 | 681513826 |
| 3 | 5cc7ad48-0918-444d-a97e-64c43852f3a6 (view SPL) | Flavoxate Hydrochloride Tablets, 100 mg Film-Coated | prescription | Human Prescription | Tagi Pharma, Inc. | 2011-02-17 | 1 | 512240154 | |
| 4 | 7a60170f-37d1-429f-9726-b4ae27015ddf (view SPL) | FLAVOXATE HYDROCHLORIDE TABLETS, 100 mg | prescription | Human Prescription | Global Pharmaceuticals | MANUFACTURE, REPACK | 2010-09-17 | 1 | 001151811 |
| 5 | 9422e67e-d64c-3ba1-b2b9-ca9d3eeda743 (view SPL) | Flavoxate Hydrochloride Tablets 100 mg, Film-CoatedRx only | prescription | Human Prescription | Avpak | 2014-09-24 | 3 | 502680324 | |
| 6 | a9c44c4b-5b3c-45bf-9bc9-ce858e3d06c5 (view SPL) | Flavoxate HCl Tablets 100 mg | prescription | Human Prescription | Paddock Laboratories, Llc | 2014-07-24 | 7 | 005740115 | |
| 7 | b4260d7e-2ab3-49f6-aa57-bae19a23d82a (view SPL) | Flavoxate Hydrochloride Tablets 100 mg, Film-CoatedRx only | prescription | Human Prescription | Epic Pharma, Llc | MANUFACTURE | 2015-03-16 | 4 | 428060058 |
| 8 | e05f4892-0be8-4178-a274-3289edca0137 (view SPL) | Flavoxate Hydrochloride Tablets, 100 mg Film-Coated | prescription | Human Prescription | Physicians Total Care, Inc. | relabel, repack | 2012-01-25 | 1 | 548686326 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII