FDA.reportPublic FDA data

Application 207000

Type
ANDA
Sponsor
SPECGX LLC

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
0406-8005Buprenorphine Hydrochloride and Naloxone Hydrochloride DihydrateBuprenorphine Hydrochloride and Naloxone Hydrochloride DihydrateSpecGx LLCANDACurrent
0406-8005Buprenorphine Hydrochloride and Naloxone Hydrochloride DihydrateBuprenorphine Hydrochloride and Naloxone Hydrochloride DihydrateSpecGx LLCANDACurrent
0406-8005Buprenorphine Hydrochloride and Naloxone Hydrochloride DihydrateBuprenorphine Hydrochloride and Naloxone Hydrochloride DihydrateSpecGx LLCANDACurrent
0406-8005Buprenorphine Hydrochloride and Naloxone Hydrochloride DihydrateBuprenorphine Hydrochloride and Naloxone Hydrochloride DihydrateSpecGx LLCANDACurrent
0406-8005Buprenorphine Hydrochloride and Naloxone Hydrochloride DihydrateBuprenorphine Hydrochloride and Naloxone Hydrochloride DihydrateSpecGx LLCANDACurrent
0406-8005Buprenorphine Hydrochloride and Naloxone Hydrochloride DihydrateBuprenorphine Hydrochloride and Naloxone Hydrochloride DihydrateSpecGx LLCANDACurrent
0406-8005Buprenorphine Hydrochloride and Naloxone Hydrochloride DihydrateBuprenorphine Hydrochloride and Naloxone Hydrochloride DihydrateSpecGx LLCANDACurrent
0406-8005Buprenorphine Hydrochloride and Naloxone Hydrochloride DihydrateBuprenorphine Hydrochloride and Naloxone Hydrochloride DihydrateSpecGx LLCANDACurrent
0406-8020Buprenorphine Hydrochloride and Naloxone Hydrochloride DihydrateBuprenorphine Hydrochloride and Naloxone Hydrochloride DihydrateSpecGx LLCANDACurrent
0406-8020Buprenorphine Hydrochloride and Naloxone Hydrochloride DihydrateBuprenorphine Hydrochloride and Naloxone Hydrochloride DihydrateSpecGx LLCANDACurrent
0406-8020Buprenorphine Hydrochloride and Naloxone Hydrochloride DihydrateBuprenorphine Hydrochloride and Naloxone Hydrochloride DihydrateSpecGx LLCANDACurrent
0406-8020Buprenorphine Hydrochloride and Naloxone Hydrochloride DihydrateBuprenorphine Hydrochloride and Naloxone Hydrochloride DihydrateSpecGx LLCANDACurrent
0406-8020Buprenorphine Hydrochloride and Naloxone Hydrochloride DihydrateBuprenorphine Hydrochloride and Naloxone Hydrochloride DihydrateSpecGx LLCANDACurrent
0406-8020Buprenorphine Hydrochloride and Naloxone Hydrochloride DihydrateBuprenorphine Hydrochloride and Naloxone Hydrochloride DihydrateSpecGx LLCANDACurrent
0406-8020Buprenorphine Hydrochloride and Naloxone Hydrochloride DihydrateBuprenorphine Hydrochloride and Naloxone Hydrochloride DihydrateSpecGx LLCANDACurrent
0406-8020Buprenorphine Hydrochloride and Naloxone Hydrochloride DihydrateBuprenorphine Hydrochloride and Naloxone Hydrochloride DihydrateSpecGx LLCANDACurrent
55700-901Buprenorphine Hydrochloride and Naloxone Hydrochloride DihydrateBuprenorphine Hydrochloride and Naloxone Hydrochloride DihydrateQuality Care Products, LLCANDACurrent
55700-901Buprenorphine Hydrochloride and Naloxone Hydrochloride DihydrateBuprenorphine Hydrochloride and Naloxone Hydrochloride DihydrateQuality Care Products, LLCANDACurrent
71335-1725Buprenorphine Hydrochloride and Naloxone Hydrochloride DihydrateBuprenorphine Hydrochloride and Naloxone Hydrochloride DihydrateBryant Ranch PrepackANDACurrent
71335-1725Buprenorphine Hydrochloride and Naloxone Hydrochloride DihydrateBuprenorphine Hydrochloride and Naloxone Hydrochloride DihydrateBryant Ranch PrepackANDACurrent
71335-1725Buprenorphine Hydrochloride and Naloxone Hydrochloride DihydrateBuprenorphine Hydrochloride and Naloxone Hydrochloride DihydrateBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76375ORIG 2023-11-06