Drugs@FDA: FDA-Approved Drugs
Company: RISING PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FLURAZEPAM HYDROCHLORIDE | FLURAZEPAM HYDROCHLORIDE | 30MG | CAPSULE;ORAL | Prescription | AB | No | Yes |
FLURAZEPAM HYDROCHLORIDE | FLURAZEPAM HYDROCHLORIDE | 15MG | CAPSULE;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 |
---|---|---|---|---|---|---|---|
06/12/1985 | 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 |
---|---|---|---|---|---|
01/17/2023 | SUPPL-26 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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02/08/2021 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
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02/06/2019 | SUPPL-20 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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12/16/2016 | SUPPL-18 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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01/15/2015 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
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09/28/2010 | SUPPL-16 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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09/18/2002 | SUPPL-11 | Labeling |
Label is not available on this site. |
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02/25/1998 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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02/05/1998 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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10/19/1993 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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04/29/1993 | SUPPL-6 | Labeling |
Label is not available on this site. |
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01/31/1990 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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06/16/1989 | SUPPL-4 | Labeling |
Label is not available on this site. |
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02/18/1988 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
FLURAZEPAM HYDROCHLORIDE
CAPSULE;ORAL; 30MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
FLURAZEPAM HYDROCHLORIDE | FLURAZEPAM HYDROCHLORIDE | 30MG | CAPSULE;ORAL | Prescription | No | AB | 072369 | CHARTWELL RX |
FLURAZEPAM HYDROCHLORIDE | FLURAZEPAM HYDROCHLORIDE | 30MG | CAPSULE;ORAL | Prescription | No | AB | 070345 | RISING PHARMA |
CAPSULE;ORAL; 15MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
FLURAZEPAM HYDROCHLORIDE | FLURAZEPAM HYDROCHLORIDE | 15MG | CAPSULE;ORAL | Prescription | No | AB | 072368 | CHARTWELL RX |
FLURAZEPAM HYDROCHLORIDE | FLURAZEPAM HYDROCHLORIDE | 15MG | CAPSULE;ORAL | Prescription | No | AB | 070345 | RISING PHARMA |