U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 208829
Company: AMNEAL PHARMS CO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription AB No No
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 7.5MG TABLET;ORAL Prescription AB No No
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription AB No No
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 15MG TABLET;ORAL Prescription AB No No
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 30MG TABLET;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/24/2017 ORIG-1 Approval STANDARD

Label is not available on this site.

BUSPIRONE HYDROCHLORIDE

TABLET;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 202557 ACCORD HLTHCARE
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 208829 AMNEAL PHARMS CO
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 078246 AUROBINDO PHARMA LTD
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 208972 EPIC PHARMA LLC
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 204582 HERITAGE PHARMA
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 074253 IMPAX LABS INC
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 209696 INVENTIA HLTHCARE
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 076008 MYLAN
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 075388 OXFORD PHARMS
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 075521 RUBICON
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 202330 STRIDES PHARMA
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 075022 TEVA
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 210907 UNICHEM
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 202087 YILING
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 078888 ZYDUS PHARMS

TABLET;ORAL; 7.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 7.5MG TABLET;ORAL Prescription No AB 202557 ACCORD HLTHCARE
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 7.5MG TABLET;ORAL Prescription No AB 208829 AMNEAL PHARMS CO
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 7.5MG TABLET;ORAL Prescription No AB 078246 AUROBINDO PHARMA LTD
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 7.5MG TABLET;ORAL Prescription No AB 208972 EPIC PHARMA LLC
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 7.5MG TABLET;ORAL Prescription No AB 209696 INVENTIA HLTHCARE
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 7.5MG TABLET;ORAL Prescription No AB 076008 MYLAN
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 7.5MG TABLET;ORAL Prescription No AB 075521 RUBICON
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 7.5MG TABLET;ORAL Prescription No AB 202330 STRIDES PHARMA

TABLET;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 202557 ACCORD HLTHCARE
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 208829 AMNEAL PHARMS CO
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 078246 AUROBINDO PHARMA LTD
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 208972 EPIC PHARMA LLC
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 204582 HERITAGE PHARMA
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 074253 IMPAX LABS INC
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 209696 INVENTIA HLTHCARE
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 076008 MYLAN
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 075388 OXFORD PHARMS
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 075521 RUBICON
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 202330 STRIDES PHARMA
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 075022 TEVA
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 210907 UNICHEM
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 202087 YILING
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 078888 ZYDUS PHARMS

TABLET;ORAL; 15MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 15MG TABLET;ORAL Prescription No AB 202557 ACCORD HLTHCARE
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 15MG TABLET;ORAL Prescription No AB 208829 AMNEAL PHARMS CO
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 15MG TABLET;ORAL Prescription No AB 078246 AUROBINDO PHARMA LTD
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 15MG TABLET;ORAL Prescription No AB 208972 EPIC PHARMA LLC
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 15MG TABLET;ORAL Prescription No AB 204582 HERITAGE PHARMA
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 15MG TABLET;ORAL Prescription No AB 074253 IMPAX LABS INC
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 15MG TABLET;ORAL Prescription No AB 209696 INVENTIA HLTHCARE
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 15MG TABLET;ORAL Prescription No AB 076008 MYLAN
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 15MG TABLET;ORAL Prescription No AB 075388 OXFORD PHARMS
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 15MG TABLET;ORAL Prescription No AB 075521 RUBICON
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 15MG TABLET;ORAL Prescription No AB 202330 STRIDES PHARMA
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 15MG TABLET;ORAL Prescription No AB 075022 TEVA
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 15MG TABLET;ORAL Prescription No AB 210907 UNICHEM
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 15MG TABLET;ORAL Prescription No AB 202087 YILING
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 15MG TABLET;ORAL Prescription No AB 078888 ZYDUS PHARMS

TABLET;ORAL; 30MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 30MG TABLET;ORAL Prescription No AB 202557 ACCORD HLTHCARE
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 30MG TABLET;ORAL Prescription No AB 208829 AMNEAL PHARMS CO
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 30MG TABLET;ORAL Prescription No AB 078246 AUROBINDO PHARMA LTD
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 30MG TABLET;ORAL Prescription No AB 208972 EPIC PHARMA LLC
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 30MG TABLET;ORAL Prescription No AB 204582 HERITAGE PHARMA
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 30MG TABLET;ORAL Prescription No AB 209696 INVENTIA HLTHCARE
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 30MG TABLET;ORAL Prescription No AB 076008 MYLAN
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 30MG TABLET;ORAL Prescription No AB 078302 OXFORD PHARMS
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 30MG TABLET;ORAL Prescription No AB 075521 RUBICON
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 30MG TABLET;ORAL Prescription No AB 202330 STRIDES PHARMA
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 30MG TABLET;ORAL Prescription No AB 075022 TEVA
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 30MG TABLET;ORAL Prescription No AB 210907 UNICHEM
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 30MG TABLET;ORAL Prescription No AB 202087 YILING
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 30MG TABLET;ORAL Prescription No AB 078888 ZYDUS PHARMS
Back to Top