Drugs@FDA: FDA-Approved Drugs
Company: WOCKHARDT BIO AG
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PROMETHAZINE PLAIN | PROMETHAZINE HYDROCHLORIDE | 6.25MG/5ML | SYRUP;ORAL | Prescription | AA | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 11/15/1982 | 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 |
|---|---|---|---|---|---|
| 04/04/2006 | SUPPL-36 | Labeling |
Label is not available on this site. |
||
| 12/21/2005 | SUPPL-35 | Labeling |
Label is not available on this site. |
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| 02/17/2000 | SUPPL-32 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/17/2000 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/17/2000 | SUPPL-30 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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| 02/17/2000 | SUPPL-29 | Labeling |
Label is not available on this site. |
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| 02/17/2000 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/05/1995 | SUPPL-22 | Labeling |
Label is not available on this site. |
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| 08/10/1994 | SUPPL-21 | Labeling |
Label is not available on this site. |
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| 02/11/1992 | SUPPL-20 | Labeling |
Label is not available on this site. |
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| 01/18/1991 | SUPPL-19 | Labeling |
Label is not available on this site. |
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| 01/19/1990 | SUPPL-18 | Labeling |
Label is not available on this site. |
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| 03/15/1989 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/16/1987 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/20/1985 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/20/1985 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/20/1985 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/20/1985 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/20/1985 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/20/1985 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/16/1985 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
PROMETHAZINE PLAIN
SYRUP;ORAL; 6.25MG/5ML
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | 6.25MG/5ML | SYRUP;ORAL | Prescription | No | AA | 040026 | CHARTWELL RX |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | 6.25MG/5ML | SYRUP;ORAL | Prescription | No | AA | 040891 | NOSTRUM LABS INC |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | 6.25MG/5ML | SYRUP;ORAL | Prescription | No | AA | 213890 | QUAGEN |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | 6.25MG/5ML | SYRUP;ORAL | Prescription | No | AA | 040718 | TARO |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | 6.25MG/5ML | SYRUP;ORAL | Prescription | No | AA | 091675 | TRIS PHARMA INC |
| PROMETHAZINE PLAIN | PROMETHAZINE HYDROCHLORIDE | 6.25MG/5ML | SYRUP;ORAL | Prescription | Yes | AA | 087953 | WOCKHARDT BIO AG |