Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040249
Company: RISING
Company: RISING
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ORPHENADRINE CITRATE | ORPHENADRINE CITRATE | 100MG | TABLET, EXTENDED RELEASE;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 |
---|---|---|---|---|---|---|---|
01/29/1999 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/40249_Orphenadrine%20Citrate_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40249ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/040249_orphenadrine_toc.cfm |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
01/29/1999 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/40249_Orphenadrine%20Citrate_Prntlbl.pdf |
ORPHENADRINE CITRATE
TABLET, EXTENDED RELEASE;ORAL; 100MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ORPHENADRINE CITRATE | ORPHENADRINE CITRATE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 091158 | BAYSHORE PHARMS LLC |
ORPHENADRINE CITRATE | ORPHENADRINE CITRATE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 040284 | LUPIN |
ORPHENADRINE CITRATE | ORPHENADRINE CITRATE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 040249 | RISING |
ORPHENADRINE CITRATE | ORPHENADRINE CITRATE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 040327 | SANDOZ |