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)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004721628ANDAActavis Pharma, Inc.2011-12-19PHENYLEPHRINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDEORALSYRUPANDA088761af19655e-918a-412a-8e2b-80dae455c445
2006031587ANDAQualitest Pharmaceuticals2006-12-07PHENYLEPHRINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDEORALSYRUPANDA040654cf73c2e3-f43b-403f-a461-47438a7270ad
3503830802ANDAHi-Tech Pharmacal Co., Inc.2015-06-16PHENYLEPHRINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDEORALSYRUPANDA0406757d0b1461-6773-4f27-9302-6a88b6f86640
4651620679ANDAAmneal Pharmaceuticals2009-08-25PHENYLEPHRINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDEORALSOLUTIONANDA040902cf4ef7c0-2f4a-4b0f-9060-ad0b909d1ed4

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1545691054ANDAA-S Medication Solutions Llc2006-12-07PHENYLEPHRINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDEORALSYRUP006031587ANDA040654cc18b582-41bb-4ae7-9eb3-e5d976df22f4
2545695736ANDAA-S Medication Solutions Llc2006-12-07PHENYLEPHRINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDEORALSYRUP006031587ANDA0406540b0cbf8f-09d5-4951-847c-6265964338cf
3548683935ANDAPhysicians Total Care, Inc.2000-09-06PHENYLEPHRINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDEORALSYRUP006031587ANDA0406541b628a38-3557-4fa4-9e08-4c7de40f9d82
4636291868ANDABryant Ranch Prepack2011-12-19PHENYLEPHRINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDEORALSYRUP004721628ANDA08876148662abd-34e2-4712-8188-56d9be21b3ad
5687886763ANDAPreferred Pharmaceuticals, Inc.2012-07-25PHENYLEPHRINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDEORALSYRUP006031587ANDA0406541ed2a01c-6521-451e-819f-7464562314a3
6687889100ANDAPreferred Pharmaceuticals, Inc.2006-12-07PHENYLEPHRINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDEORALSYRUP006031587ANDA040654b00b296d-6c34-48c8-9cfb-71ccc5c9a908

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA040654PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDEVINTAGE PHARMACEUTICALS LLC2006-12-07ANDA040654_001
2ANDA040675PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDEHI-TECH PHARMACAL CO INC2014-12-23ANDA040675_001
3ANDA040902PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDEAMNEAL PHARMACEUTICALS2009-08-25ANDA040902_001
4ANDA088761PROMETH VC PLAING AND W LABORATORIES INC1984-11-08ANDA088761_001
5ANDA088815PROMETHAZINE VC PLAINTrueHR CENCI LABORATORIES INC1985-11-22ANDA088815_001
6ANDA088868PHERAZINE VCTrueHALSEY DRUG CO INC1987-03-02ANDA088868_001
7ANDA088897PROMETHAZINE VC PLAINTrueWOCKHARDT EU OPERATIONS (SWISS) AG1985-01-04ANDA088897_001
8NDA008604PHENERGAN VCTrueANI PHARMACEUTICALS INC1984-04-02NDA008604_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA040654_001RXPROMETHAZINE HYDROCHLORIDE (6.25MG/5ML), PHENYLEPHRINE HYDROCHLORIDE (5MG/5ML)ORALSYRUPFalseAA2006-12-07PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE
2ANDA040675_001RXPHENYLEPHRINE HYDROCHLORIDE (5MG/5ML), PROMETHAZINE HYDROCHLORIDE (6.25MG/5ML)ORALSYRUPFalseAA2014-12-23PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE
3ANDA040902_001RXPROMETHAZINE HYDROCHLORIDE (6.25MG/5ML), PHENYLEPHRINE HYDROCHLORIDE (5MG/5ML)ORALSYRUPFalseAA2009-08-25PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE
4ANDA088761_001RXPROMETHAZINE HYDROCHLORIDE (6.25MG/5ML), PHENYLEPHRINE HYDROCHLORIDE (5MG/5ML)ORALSYRUPTrueAA1984-11-08PROMETH VC PLAIN
5ANDA088815_001discontinuedPROMETHAZINE HYDROCHLORIDE (6.25MG/5ML), PHENYLEPHRINE HYDROCHLORIDE (5MG/5ML)ORALSYRUPFalse1985-11-22PROMETHAZINE VC PLAIN
6ANDA088868_001discontinuedPROMETHAZINE HYDROCHLORIDE (6.25MG/5ML), PHENYLEPHRINE HYDROCHLORIDE (5MG/5ML)ORALSYRUPFalse1987-03-02PHERAZINE VC
7ANDA088897_001discontinuedPROMETHAZINE HYDROCHLORIDE (6.25MG/5ML), PHENYLEPHRINE HYDROCHLORIDE (5MG/5ML)ORALSYRUPFalse1985-01-04PROMETHAZINE VC PLAIN
8NDA008604_003discontinuedPHENYLEPHRINE HYDROCHLORIDE (5MG/5ML), PROMETHAZINE HYDROCHLORIDE (6.25MG/5ML)ORALSYRUPFalse1984-04-02PHENERGAN VC

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10b0cbf8f-09d5-4951-847c-6265964338cf (view SPL)PROMETHAZINE VC SYRUP (PROMETHAZINE HYDROCHLORIDE, USP AND PHENYLEPHRINE HYDROCHLORIDE, USP)prescriptionHuman PrescriptionA-S Medication Solutions Llcrelabel2013-06-171545695736
21b628a38-3557-4fa4-9e08-4c7de40f9d82 (view SPL)PROMETHAZINE VC SYRUP (PROMETHAZINE HYDROCHLORIDE, USP AND PHENYLEPHRINE HYDROCHLORIDE, USP)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2012-08-314548683935
31ed2a01c-6521-451e-819f-7464562314a3 (view SPL)PROMETHAZINE VC SYRUP (PROMETHAZINE HYDROCHLORIDE, USP AND PHENYLEPHRINE HYDROCHLORIDE, USP)prescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.RELABEL2015-01-162687886763
448662abd-34e2-4712-8188-56d9be21b3ad (view SPL)PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE SYRUPprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2014-07-281000636291868
57d0b1461-6773-4f27-9302-6a88b6f86640 (view SPL)Promethazine Hydrochloride and Phenylephrine Hydrochloride SyrupprescriptionHuman PrescriptionHi-Tech Pharmacal Co., Inc.MANUFACTURE2015-06-084503830802
6af19655e-918a-412a-8e2b-80dae455c445 (view SPL)PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE SYRUPprescriptionHuman PrescriptionActavis Pharma, Inc.MANUFACTURE2007-07-092004721628
7b00b296d-6c34-48c8-9cfb-71ccc5c9a908 (view SPL)PROMETHAZINE VC SYRUP (PROMETHAZINE HYDROCHLORIDE, USP AND PHENYLEPHRINE HYDROCHLORIDE, USP)prescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.relabel2011-06-101687889100
8cc18b582-41bb-4ae7-9eb3-e5d976df22f4 (view SPL)PROMETHAZINE VC SYRUP (PROMETHAZINE HYDROCHLORIDE, USP AND PHENYLEPHRINE HYDROCHLORIDE, USP)prescriptionHuman PrescriptionA-S Medication Solutions Llcrelabel2013-06-171545691054
9cf4ef7c0-2f4a-4b0f-9060-ad0b909d1ed4 (view SPL)PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE ORAL SOLUTION, USP 6.25 mg and 5 mg/5 mL Rx OnlyprescriptionHuman PrescriptionAmneal PharmaceuticalsANALYSIS, LABEL, MANUFACTURE, PACK2015-05-227651620679
10cf73c2e3-f43b-403f-a461-47438a7270ad (view SPL)PROMETHAZINE VC SYRUP (PROMETHAZINE HYDROCHLORIDE, USP AND PHENYLEPHRINE HYDROCHLORIDE, USP)prescriptionHuman PrescriptionQualitest PharmaceuticalsMANUFACTURE2015-02-056006031587

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII