Drugs@FDA: FDA-Approved Drugs
Company: WOCKHARDT BIO AG
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE | CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE | 10MG/5ML;6.25MG/5ML | SYRUP;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 |
|---|---|---|---|---|---|---|---|
| 12/17/1984 | 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 |
|---|---|---|---|---|---|
| 06/28/2018 | SUPPL-39 | Labeling-Package Insert |
Label is not available on this site. |
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| 11/17/2017 | SUPPL-38 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/13/2017 | SUPPL-37 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 05/10/2013 | SUPPL-35 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/29/2015 | SUPPL-34 | Labeling-Package Insert |
Label is not available on this site. |
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| 01/21/2010 | SUPPL-32 | Labeling |
Label is not available on this site. |
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| 12/19/2008 | SUPPL-31 | Labeling |
Label is not available on this site. |
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| 02/25/2008 | SUPPL-30 | Labeling |
Label is not available on this site. |
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| 04/03/2006 | SUPPL-29 | Labeling |
Label is not available on this site. |
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| 06/27/2002 | SUPPL-26 | Labeling |
Label is not available on this site. |
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| 06/27/2002 | SUPPL-25 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/27/2002 | SUPPL-24 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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| 01/18/1991 | SUPPL-17 | Labeling |
Label is not available on this site. |
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| 08/23/1990 | SUPPL-16 | Labeling |
Label is not available on this site. |
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| 01/31/1990 | SUPPL-15 | Labeling |
Label is not available on this site. |
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| 04/05/1989 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/08/1988 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/07/1987 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/07/1987 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/07/1987 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/07/1987 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/07/1987 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/05/1986 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/05/1986 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE
SYRUP;ORAL; 10MG/5ML;6.25MG/5ML
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE | CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE | 10MG/5ML;6.25MG/5ML | SYRUP;ORAL | Prescription | No | AA | 200894 | AMNEAL PHARMS |
| PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE | CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE | 10MG/5ML;6.25MG/5ML | SYRUP;ORAL | Prescription | No | AA | 090180 | NOSTRUM LABS INC |
| PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE | CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE | 10MG/5ML;6.25MG/5ML | SYRUP;ORAL | Prescription | No | AA | 214238 | QUAGEN |
| PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE | CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE | 10MG/5ML;6.25MG/5ML | SYRUP;ORAL | Prescription | No | AA | 200386 | TRIS PHARMA INC |
| PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE | CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE | 10MG/5ML;6.25MG/5ML | SYRUP;ORAL | Prescription | No | AA | 088875 | WOCKHARDT BIO AG |
| PROMETHAZINE WITH CODEINE | CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE | 10MG/5ML;6.25MG/5ML | SYRUP;ORAL | Prescription | No | AA | 040650 | PHARM ASSOC |