Drugs@FDA: FDA-Approved Drugs
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. |
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02/19/1999 | SUPPL-17 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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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. |
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04/03/1996 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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08/16/1995 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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12/12/1994 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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09/27/1990 | SUPPL-11 | Labeling |
Label is not available on this site. |
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11/18/1988 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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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. |
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05/28/1986 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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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 |