FDA.reportPublic FDA data

Application 204431

Type
ANDA
Sponsor
ETHYPHARM USA CORP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEBUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDETABLET;SUBLINGUALEQ 2MG BASE;EQ 0.5MG BASENoNo
002BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEBUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDETABLET;SUBLINGUALEQ 8MG BASE;EQ 2MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50383-287Buprenorphine and Naloxonebuprenorphine hydrochloride and naloxone hydrochlorideHi-Tech Pharmacal Co. Inc.ANDACurrent
50383-287Buprenorphine and Naloxonebuprenorphine hydrochloride and naloxone hydrochlorideAkorn Operating Company LLC (dba Akorn)ANDACurrent
50383-287Buprenorphine and Naloxonebuprenorphine hydrochloride and naloxone hydrochlorideHi-Tech Pharmacal Co. Inc.ANDACurrent
50383-287Buprenorphine and Naloxonebuprenorphine hydrochloride and naloxone hydrochlorideHi-Tech Pharmacal Co. Inc.ANDACurrent
50383-287Buprenorphine and Naloxonebuprenorphine hydrochloride and naloxone hydrochlorideHi-Tech Pharmacal Co. Inc.ANDACurrent
50383-287Buprenorphine and Naloxonebuprenorphine hydrochloride and naloxone hydrochlorideHi-Tech Pharmacal Co. IncANDACurrent
50383-287Buprenorphine and Naloxonebuprenorphine hydrochloride and naloxone hydrochlorideHi-Tech Pharmacal Co. Inc.ANDACurrent
50383-294Buprenorphine and Naloxonebuprenorphine hydrochloride and naloxone hydrochlorideAkorn Operating Company LLC (dba Akorn)ANDACurrent
50383-294Buprenorphine and Naloxonebuprenorphine hydrochloride and naloxone hydrochlorideHi-Tech Pharmacal Co. IncANDACurrent
50383-294Buprenorphine and Naloxonebuprenorphine hydrochloride and naloxone hydrochlorideHi-Tech Pharmacal Co. Inc.ANDACurrent
50383-294Buprenorphine and Naloxonebuprenorphine hydrochloride and naloxone hydrochlorideHi-Tech Pharmacal Co. Inc.ANDACurrent
50383-294Buprenorphine and Naloxonebuprenorphine hydrochloride and naloxone hydrochlorideHi-Tech Pharmacal Co. Inc.ANDACurrent
50383-294Buprenorphine and Naloxonebuprenorphine hydrochloride and naloxone hydrochlorideHi-Tech Pharmacal Co. Inc.ANDACurrent
50383-294Buprenorphine and Naloxonebuprenorphine hydrochloride and naloxone hydrochlorideHi-Tech Pharmacal Co. Inc.ANDACurrent
53217-138Buprenorphine and Naloxonebuprenorphine hydrochloride and naloxone hydrochlorideAidarex Pharmaceuticals LLCANDACurrent
60429-586Buprenorphine and Naloxonebuprenorphine hydrochloride and naloxone hydrochlorideGolden State Medical Supply Inc.ANDACurrent
60429-586Buprenorphine and Naloxonebuprenorphine hydrochloride and naloxone hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-586Buprenorphine and Naloxonebuprenorphine hydrochloride and naloxone hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-586Buprenorphine and Naloxonebuprenorphine hydrochloride and naloxone hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-586Buprenorphine and Naloxonebuprenorphine hydrochloride and naloxone hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-586Buprenorphine and Naloxonebuprenorphine hydrochloride and naloxone hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-586Buprenorphine and Naloxonebuprenorphine hydrochloride and naloxone hydrochlorideGolden State Medical Supply Inc.ANDACurrent
60429-586Buprenorphine and Naloxonebuprenorphine hydrochloride and naloxone hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-587Buprenorphine and Naloxonebuprenorphine hydrochloride and naloxone hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-587Buprenorphine and Naloxonebuprenorphine hydrochloride and naloxone hydrochlorideGolden State Medical Supply Inc.ANDACurrent
60429-587Buprenorphine and Naloxonebuprenorphine hydrochloride and naloxone hydrochlorideGolden State Medical Supply Inc.ANDACurrent
60429-587Buprenorphine and Naloxonebuprenorphine hydrochloride and naloxone hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-587Buprenorphine and Naloxonebuprenorphine hydrochloride and naloxone hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-587Buprenorphine and Naloxonebuprenorphine hydrochloride and naloxone hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-587Buprenorphine and Naloxonebuprenorphine hydrochloride and naloxone hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-587Buprenorphine and Naloxonebuprenorphine hydrochloride and naloxone hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
63629-7270Buprenorphine and Naloxonebuprenorphine hydrochloride and naloxone hydrochlorideBryant Ranch PrepackANDACurrent
63629-7270Buprenorphine and Naloxonebuprenorphine hydrochloride and naloxone hydrochlorideBryant Ranch PrepackANDACurrent
63629-7270Buprenorphine and Naloxonebuprenorphine hydrochloride and naloxone hydrochlorideBryant Ranch PrepackANDACurrent
63629-7270Buprenorphine and Naloxonebuprenorphine hydrochloride and naloxone hydrochlorideBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44593ORIG2016-02-03
19561ORIG2015-11-25
32560ORIG2015-10-21