Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040284
Company: LUPIN
Company: LUPIN
| 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 | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 06/19/1998 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/40284ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/14/2024 | SUPPL-25 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 01/28/2014 | SUPPL-21 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/27/2009 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 10/08/2002 | SUPPL-11 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/08/2002 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/08/2002 | SUPPL-9 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 10/08/2002 | SUPPL-8 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 03/22/2002 | SUPPL-7 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/22/2002 | SUPPL-6 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 07/24/2002 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/24/2002 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/19/1998 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
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 |