Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 205085
Company: ORIENT PHARMA CO LTD
Company: ORIENT PHARMA CO LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CARISOPRODOL | CARISOPRODOL | 350MG | TABLET;ORAL | Prescription | AA | 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 |
---|---|---|---|---|---|---|---|
10/27/2014 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/27/2020 | SUPPL-3 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
CARISOPRODOL
TABLET;ORAL; 350MG
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CARISOPRODOL | CARISOPRODOL | 350MG | TABLET;ORAL | Prescription | No | AA | 040576 | ACCELRX LABS |
CARISOPRODOL | CARISOPRODOL | 350MG | TABLET;ORAL | Prescription | No | AA | 040792 | AUROBINDO PHARMA |
CARISOPRODOL | CARISOPRODOL | 350MG | TABLET;ORAL | Prescription | No | AA | 040245 | CHARTWELL RX |
CARISOPRODOL | CARISOPRODOL | 350MG | TABLET;ORAL | Prescription | No | AA | 211789 | MLV |
CARISOPRODOL | CARISOPRODOL | 350MG | TABLET;ORAL | Prescription | No | AA | 090988 | NATCO |
CARISOPRODOL | CARISOPRODOL | 350MG | TABLET;ORAL | Prescription | No | AA | 207237 | NOSTRUM LABS INC |
CARISOPRODOL | CARISOPRODOL | 350MG | TABLET;ORAL | Prescription | No | AA | 040823 | NOVAST LABS |
CARISOPRODOL | CARISOPRODOL | 350MG | TABLET;ORAL | Prescription | No | AA | 205085 | ORIENT PHARMA CO LTD |
CARISOPRODOL | CARISOPRODOL | 350MG | TABLET;ORAL | Prescription | No | AA | 040188 | OXFORD PHARMS |
CARISOPRODOL | CARISOPRODOL | 350MG | TABLET;ORAL | Prescription | No | AA | 203374 | SCIEGEN PHARMS INC |
CARISOPRODOL | CARISOPRODOL | 350MG | TABLET;ORAL | Prescription | No | AA | 081025 | WANBANG BIOPHARMS |
CARISOPRODOL | CARISOPRODOL | 350MG | TABLET;ORAL | Prescription | No | AA | 087499 | WATSON LABS |
CARISOPRODOL | CARISOPRODOL | 350MG | TABLET;ORAL | Prescription | No | AA | 205126 | WILSHIRE PHARMS INC |
SOMA | CARISOPRODOL | 350MG | TABLET;ORAL | Prescription | Yes | AA | 011792 | MYLAN SPECIALITY LP |