Drugs@FDA: FDA Approved Drug Products
Company: ACTAVIS MID ATLANTIC
| 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 | 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 |
|---|---|---|---|---|---|---|---|
| 10/31/1984 | 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-89 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/19/2018 | SUPPL-88 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 08/29/2017 | SUPPL-87 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 01/13/2017 | SUPPL-86 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 02/19/2014 | SUPPL-83 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/27/2009 | SUPPL-78 | Labeling |
Label is not available on this site. |
||
| 12/19/2008 | SUPPL-74 | Labeling |
Label is not available on this site. |
||
| 10/06/2005 | SUPPL-60 | Labeling |
Label is not available on this site. |
||
| 05/02/2005 | SUPPL-54 | Labeling |
Label is not available on this site. |
||
| 06/06/2003 | SUPPL-47 | Labeling |
Label is not available on this site. |
||
| 10/03/2001 | SUPPL-46 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/03/2001 | SUPPL-45 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/02/2000 | SUPPL-44 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/01/1998 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/01/1998 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/15/1997 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/21/1996 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/18/1996 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/07/1996 | SUPPL-33 | Labeling |
Label is not available on this site. |
||
| 05/07/1996 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/07/1996 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/23/1995 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/07/1996 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/07/1996 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/30/1996 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/30/1996 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/29/1994 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/03/1993 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/05/1993 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/28/1990 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/24/1990 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 11/03/1989 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 06/21/1989 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/21/1989 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/21/1989 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/15/1988 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/15/1988 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/10/1987 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/10/1987 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/18/1987 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/13/1987 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/18/1986 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/14/1985 | SUPPL-2 | 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 | 088763 | ACTAVIS MID ATLANTIC |
| 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 | 040151 | HI TECH PHARMA |
| 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 | 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 | VINTAGE |
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English