FDA.reportPublic FDA data

Application 203136

Type
ANDA
Sponsor
AMNEAL PHARMS

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
0406-1923Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneSpecGx LLCANDACurrent
0406-1923Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneMallinckrodt, Inc.ANDACurrent
0406-1923Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneSpecGx LLCANDACurrent
0406-1924Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneMallinckrodt, Inc.ANDACurrent
0406-1924Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneSpecGx LLCANDACurrent
0406-1924Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneSpecGx LLCANDACurrent
42291-174Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneAvKARE, Inc.ANDACurrent
42291-174Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneAvKARE, Inc.ANDACurrent
42291-175Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneAvKARE, Inc.ANDACurrent
42291-175Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneAvKARE, Inc.ANDACurrent
42291-175Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneAvKARE, Inc.ANDACurrent
50268-144Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneAvPAKANDACurrent
50268-144Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneAvPAKANDACurrent
50268-144Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneAvPAKANDACurrent
50268-144Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneAvPAKANDACurrent
50268-145Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneAvPAKANDACurrent
50268-145Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneAvPAKANDACurrent
50268-145Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneAvPAKANDACurrent
50268-145Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneAvPAKANDACurrent
63629-7269Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneBryant Ranch PrepackANDACurrent
63629-7269Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneBryant Ranch PrepackANDACurrent
65162-415Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneAmneal Pharmaceuticals LLCANDACurrent
65162-415Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneAmneal Pharmaceuticals LLCANDACurrent
65162-415Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneAmneal Pharmaceuticals LLCANDACurrent
65162-415Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneAmneal Pharmaceuticals LLCANDACurrent
65162-415Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneAmneal Pharmaceuticals LLCANDACurrent
65162-415Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneAmneal Pharmaceuticals LLCANDACurrent
65162-415Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneAmneal Pharmaceuticals LLCANDACurrent
65162-415Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneAmneal Pharmaceuticals LLCANDACurrent
65162-416Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneAmneal Pharmaceuticals LLCANDACurrent
65162-416Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneAmneal Pharmaceuticals LLCANDACurrent
65162-416Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneAmneal Pharmaceuticals LLCANDACurrent
65162-416Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneAmneal Pharmaceuticals LLCANDACurrent
65162-416Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneAmneal Pharmaceuticals LLCANDACurrent
65162-416Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneAmneal Pharmaceuticals LLCANDACurrent
65162-416Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneAmneal Pharmaceuticals LLCANDACurrent
65162-416Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneAmneal Pharmaceuticals LLCANDACurrent
70518-1007Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneREMEDYREPACK INC.ANDACurrent
70518-1007Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneREMEDYREPACK INC.ANDACurrent
70518-1007Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneREMEDYREPACK INC.ANDACurrent
70518-1007Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneREMEDYREPACK INC.ANDACurrent
70518-1007Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneREMEDYREPACK INC.ANDACurrent
70518-1007Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneREMEDYREPACK INC.ANDACurrent
70518-1007Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneREMEDYREPACK INC.ANDACurrent
70518-1684Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneREMEDYREPACK INC.ANDACurrent
70518-1684Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneREMEDYREPACK INC.ANDACurrent
71335-1514Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneBryant Ranch PrepackANDACurrent
71335-1514Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneBryant Ranch PrepackANDACurrent
71335-1514Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44587ORIG2015-07-02
10167SUPPL2014-05-29
32381ORIG2013-02-26