Phenylephrine / Promethazine Oral Solution
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Actavis Pharma, Inc. (2007-07-09)
- Oldest Current Product
- 2000-09-06
- License(s)
- ANDA
- RxNORM
- ORAL SOLUTION\PHENYLEPHRINE:PROMETHAZINE
- FDAOB
- ORAL\SYRUP\PHENYLEPHRINE HYDROCHLORIDE: PROMETHAZINE HYDROCHLORIDE
- SPL Active
- ORAL\SOLUTION\PHENYLEPHRINE HYDROCHLORIDE: PROMETHAZINE HYDROCHLORIDE
ORAL\SYRUP\PHENYLEPHRINE HYDROCHLORIDE: PROMETHAZINE HYDROCHLORIDE - SPL Moiety
- ORAL\SOLUTION\PHENYLEPHRINE: PROMETHAZINE
ORAL\SYRUP\PHENYLEPHRINE: PROMETHAZINE
product(s) by strength(s)
phenylephrine hydrochloride 1 mg/ml / promethazine hydrochloride 1.25 mg/ml oral solution
generic product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 004721628 | ANDA | Actavis Pharma, Inc. | 2011-12-19 | PHENYLEPHRINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE | ORAL | SYRUP | ANDA088761 | af19655e-918a-412a-8e2b-80dae455c445 |
| 2 | 006031587 | ANDA | Qualitest Pharmaceuticals | 2006-12-07 | PHENYLEPHRINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE | ORAL | SYRUP | ANDA040654 | cf73c2e3-f43b-403f-a461-47438a7270ad |
| 3 | 503830802 | ANDA | Hi-Tech Pharmacal Co., Inc. | 2015-06-16 | PHENYLEPHRINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE | ORAL | SYRUP | ANDA040675 | 7d0b1461-6773-4f27-9302-6a88b6f86640 |
| 4 | 651620679 | ANDA | Amneal Pharmaceuticals | 2009-08-25 | PHENYLEPHRINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE | ORAL | SOLUTION | ANDA040902 | cf4ef7c0-2f4a-4b0f-9060-ad0b909d1ed4 |
relabeler product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | equivalent product | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 545691054 | ANDA | A-S Medication Solutions Llc | 2006-12-07 | PHENYLEPHRINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE | ORAL | SYRUP | 006031587 | ANDA040654 | cc18b582-41bb-4ae7-9eb3-e5d976df22f4 |
| 2 | 545695736 | ANDA | A-S Medication Solutions Llc | 2006-12-07 | PHENYLEPHRINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE | ORAL | SYRUP | 006031587 | ANDA040654 | 0b0cbf8f-09d5-4951-847c-6265964338cf |
| 3 | 548683935 | ANDA | Physicians Total Care, Inc. | 2000-09-06 | PHENYLEPHRINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE | ORAL | SYRUP | 006031587 | ANDA040654 | 1b628a38-3557-4fa4-9e08-4c7de40f9d82 |
| 4 | 636291868 | ANDA | Bryant Ranch Prepack | 2011-12-19 | PHENYLEPHRINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE | ORAL | SYRUP | 004721628 | ANDA088761 | 48662abd-34e2-4712-8188-56d9be21b3ad |
| 5 | 687886763 | ANDA | Preferred Pharmaceuticals, Inc. | 2012-07-25 | PHENYLEPHRINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE | ORAL | SYRUP | 006031587 | ANDA040654 | 1ed2a01c-6521-451e-819f-7464562314a3 |
| 6 | 687889100 | ANDA | Preferred Pharmaceuticals, Inc. | 2006-12-07 | PHENYLEPHRINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE | ORAL | SYRUP | 006031587 | ANDA040654 | b00b296d-6c34-48c8-9cfb-71ccc5c9a908 |
application(s)
| # | id | title | deprecated | applicant | approved | approved drug |
|---|---|---|---|---|---|---|
| 1 | ANDA040654 | PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE | VINTAGE PHARMACEUTICALS LLC | 2006-12-07 | ANDA040654_001 | |
| 2 | ANDA040675 | PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE | HI-TECH PHARMACAL CO INC | 2014-12-23 | ANDA040675_001 | |
| 3 | ANDA040902 | PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE | AMNEAL PHARMACEUTICALS | 2009-08-25 | ANDA040902_001 | |
| 4 | ANDA088761 | PROMETH VC PLAIN | G AND W LABORATORIES INC | 1984-11-08 | ANDA088761_001 | |
| 5 | ANDA088815 | PROMETHAZINE VC PLAIN | True | HR CENCI LABORATORIES INC | 1985-11-22 | ANDA088815_001 |
| 6 | ANDA088868 | PHERAZINE VC | True | HALSEY DRUG CO INC | 1987-03-02 | ANDA088868_001 |
| 7 | ANDA088897 | PROMETHAZINE VC PLAIN | True | WOCKHARDT EU OPERATIONS (SWISS) AG | 1985-01-04 | ANDA088897_001 |
| 8 | NDA008604 | PHENERGAN VC | True | ANI PHARMACEUTICALS INC | 1984-04-02 | NDA008604_003 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | route | dose form | rld | TE | approved | application |
|---|---|---|---|---|---|---|---|---|---|
| 1 | ANDA040654_001 | RX | PROMETHAZINE HYDROCHLORIDE (6.25MG/5ML), PHENYLEPHRINE HYDROCHLORIDE (5MG/5ML) | ORAL | SYRUP | False | AA | 2006-12-07 | PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE |
| 2 | ANDA040675_001 | RX | PHENYLEPHRINE HYDROCHLORIDE (5MG/5ML), PROMETHAZINE HYDROCHLORIDE (6.25MG/5ML) | ORAL | SYRUP | False | AA | 2014-12-23 | PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE |
| 3 | ANDA040902_001 | RX | PROMETHAZINE HYDROCHLORIDE (6.25MG/5ML), PHENYLEPHRINE HYDROCHLORIDE (5MG/5ML) | ORAL | SYRUP | False | AA | 2009-08-25 | PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE |
| 4 | ANDA088761_001 | RX | PROMETHAZINE HYDROCHLORIDE (6.25MG/5ML), PHENYLEPHRINE HYDROCHLORIDE (5MG/5ML) | ORAL | SYRUP | True | AA | 1984-11-08 | PROMETH VC PLAIN |
| 5 | ANDA088815_001 | discontinued | PROMETHAZINE HYDROCHLORIDE (6.25MG/5ML), PHENYLEPHRINE HYDROCHLORIDE (5MG/5ML) | ORAL | SYRUP | False | 1985-11-22 | PROMETHAZINE VC PLAIN | |
| 6 | ANDA088868_001 | discontinued | PROMETHAZINE HYDROCHLORIDE (6.25MG/5ML), PHENYLEPHRINE HYDROCHLORIDE (5MG/5ML) | ORAL | SYRUP | False | 1987-03-02 | PHERAZINE VC | |
| 7 | ANDA088897_001 | discontinued | PROMETHAZINE HYDROCHLORIDE (6.25MG/5ML), PHENYLEPHRINE HYDROCHLORIDE (5MG/5ML) | ORAL | SYRUP | False | 1985-01-04 | PROMETHAZINE VC PLAIN | |
| 8 | NDA008604_003 | discontinued | PHENYLEPHRINE HYDROCHLORIDE (5MG/5ML), PROMETHAZINE HYDROCHLORIDE (6.25MG/5ML) | ORAL | SYRUP | False | 1984-04-02 | PHENERGAN VC |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 0b0cbf8f-09d5-4951-847c-6265964338cf (view SPL) | PROMETHAZINE VC SYRUP (PROMETHAZINE HYDROCHLORIDE, USP AND PHENYLEPHRINE HYDROCHLORIDE, USP) | prescription | Human Prescription | A-S Medication Solutions Llc | relabel | 2013-06-17 | 1 | 545695736 |
| 2 | 1b628a38-3557-4fa4-9e08-4c7de40f9d82 (view SPL) | PROMETHAZINE VC SYRUP (PROMETHAZINE HYDROCHLORIDE, USP AND PHENYLEPHRINE HYDROCHLORIDE, USP) | prescription | Human Prescription | Physicians Total Care, Inc. | relabel | 2012-08-31 | 4 | 548683935 |
| 3 | 1ed2a01c-6521-451e-819f-7464562314a3 (view SPL) | PROMETHAZINE VC SYRUP (PROMETHAZINE HYDROCHLORIDE, USP AND PHENYLEPHRINE HYDROCHLORIDE, USP) | prescription | Human Prescription | Preferred Pharmaceuticals, Inc. | RELABEL | 2015-01-16 | 2 | 687886763 |
| 4 | 48662abd-34e2-4712-8188-56d9be21b3ad (view SPL) | PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE SYRUP | prescription | Human Prescription | Bryant Ranch Prepack | RELABEL, REPACK | 2014-07-28 | 1000 | 636291868 |
| 5 | 7d0b1461-6773-4f27-9302-6a88b6f86640 (view SPL) | Promethazine Hydrochloride and Phenylephrine Hydrochloride Syrup | prescription | Human Prescription | Hi-Tech Pharmacal Co., Inc. | MANUFACTURE | 2015-06-08 | 4 | 503830802 |
| 6 | af19655e-918a-412a-8e2b-80dae455c445 (view SPL) | PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE SYRUP | prescription | Human Prescription | Actavis Pharma, Inc. | MANUFACTURE | 2007-07-09 | 2 | 004721628 |
| 7 | b00b296d-6c34-48c8-9cfb-71ccc5c9a908 (view SPL) | PROMETHAZINE VC SYRUP (PROMETHAZINE HYDROCHLORIDE, USP AND PHENYLEPHRINE HYDROCHLORIDE, USP) | prescription | Human Prescription | Preferred Pharmaceuticals, Inc. | relabel | 2011-06-10 | 1 | 687889100 |
| 8 | cc18b582-41bb-4ae7-9eb3-e5d976df22f4 (view SPL) | PROMETHAZINE VC SYRUP (PROMETHAZINE HYDROCHLORIDE, USP AND PHENYLEPHRINE HYDROCHLORIDE, USP) | prescription | Human Prescription | A-S Medication Solutions Llc | relabel | 2013-06-17 | 1 | 545691054 |
| 9 | cf4ef7c0-2f4a-4b0f-9060-ad0b909d1ed4 (view SPL) | PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE ORAL SOLUTION, USP 6.25 mg and 5 mg/5 mL Rx Only | prescription | Human Prescription | Amneal Pharmaceuticals | ANALYSIS, LABEL, MANUFACTURE, PACK | 2015-05-22 | 7 | 651620679 |
| 10 | cf73c2e3-f43b-403f-a461-47438a7270ad (view SPL) | PROMETHAZINE VC SYRUP (PROMETHAZINE HYDROCHLORIDE, USP AND PHENYLEPHRINE HYDROCHLORIDE, USP) | prescription | Human Prescription | Qualitest Pharmaceuticals | MANUFACTURE | 2015-02-05 | 6 | 006031587 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII