Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 080983
Company: SAPTALIS PHARMS
Company: SAPTALIS PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SONAZINE | CHLORPROMAZINE HYDROCHLORIDE | 30MG/ML | CONCENTRATE;ORAL | Prescription | AA | No | No |
| SONAZINE | CHLORPROMAZINE HYDROCHLORIDE | 100MG/ML | CONCENTRATE;ORAL | Prescription | AA | 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 |
|---|---|---|---|---|---|---|---|
| 03/01/1976 | 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 |
|---|---|---|---|---|---|
| 04/14/2026 | SUPPL-63 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 02/26/2025 | SUPPL-62 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
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| 02/05/2020 | SUPPL-61 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/23/2017 | SUPPL-60 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/12/2015 | SUPPL-59 | Labeling-Package Insert |
Label is not available on this site. |
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| 01/24/1994 | SUPPL-54 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/04/1992 | SUPPL-53 | Labeling |
Label is not available on this site. |
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| 02/16/1990 | SUPPL-48 | Labeling |
Label is not available on this site. |
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| 05/19/1988 | SUPPL-45 | Labeling |
Label is not available on this site. |
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| 05/29/1986 | SUPPL-42 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/08/1985 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/18/1984 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/07/1983 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/12/1983 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/18/1983 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/03/1982 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
SONAZINE
CONCENTRATE;ORAL; 30MG/ML
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 30MG/ML | CONCENTRATE;ORAL | Prescription | No | AA | 214542 | GENUS |
| CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 30MG/ML | CONCENTRATE;ORAL | Prescription | No | AA | 216678 | RUBICON RESEARCH |
| SONAZINE | CHLORPROMAZINE HYDROCHLORIDE | 30MG/ML | CONCENTRATE;ORAL | Prescription | No | AA | 080983 | SAPTALIS PHARMS |
CONCENTRATE;ORAL; 100MG/ML
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 100MG/ML | CONCENTRATE;ORAL | Prescription | No | AA | 214542 | GENUS |
| CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 100MG/ML | CONCENTRATE;ORAL | Prescription | No | AA | 216678 | RUBICON RESEARCH |
| SONAZINE | CHLORPROMAZINE HYDROCHLORIDE | 100MG/ML | CONCENTRATE;ORAL | Prescription | No | AA | 080983 | SAPTALIS PHARMS |