Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 084779
Company: WATSON LABS
Company: WATSON LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ORPHENADRINE CITRATE | ORPHENADRINE CITRATE | 30MG/ML | INJECTABLE;INJECTION | Prescription | AP | 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 |
|---|---|---|---|---|---|---|---|
| 03/15/1982 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/16/2007 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 02/19/1999 | SUPPL-17 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 02/02/1999 | SUPPL-16 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 06/20/1997 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/03/1996 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/16/1995 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/12/1994 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/27/1990 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 11/18/1988 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/18/1988 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/23/1988 | SUPPL-6 | Bioequivalence |
Label is not available on this site. |
||
| 05/28/1986 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/17/1984 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
ORPHENADRINE CITRATE
INJECTABLE;INJECTION; 30MG/ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ORPHENADRINE CITRATE | ORPHENADRINE CITRATE | 30MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 040463 | HIKMA |
| ORPHENADRINE CITRATE | ORPHENADRINE CITRATE | 30MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 040484 | RISING |
| ORPHENADRINE CITRATE | ORPHENADRINE CITRATE | 30MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 090585 | SAGENT PHARMS |
| ORPHENADRINE CITRATE | ORPHENADRINE CITRATE | 30MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 084779 | WATSON LABS |