Drugs@FDA: FDA-Approved Drugs
Company: COSETTE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | 25MG | SUPPOSITORY;RECTAL | Prescription | AB | No | Yes |
PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | 12.5MG | SUPPOSITORY;RECTAL | 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 |
---|---|---|---|---|---|---|---|
02/05/2002 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/040428.PDF |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/02/2016 | SUPPL-31 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
12/18/2012 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
12/18/2012 | SUPPL-25 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
05/26/2010 | SUPPL-24 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
04/26/2010 | SUPPL-23 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
10/13/2005 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
10/06/2004 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
06/18/2004 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
03/31/2003 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
03/31/2003 | SUPPL-2 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |
||
11/20/2002 | SUPPL-1 | Labeling |
Label is not available on this site. |
PROMETHAZINE HYDROCHLORIDE
SUPPOSITORY;RECTAL; 25MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | 25MG | SUPPOSITORY;RECTAL | Prescription | No | AB | 040428 | COSETTE |
PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | 25MG | SUPPOSITORY;RECTAL | Prescription | No | AB | 040500 | PERRIGO ISRAEL |
PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | 25MG | SUPPOSITORY;RECTAL | Prescription | No | AB | 040603 | TARO |
SUPPOSITORY;RECTAL; 12.5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | 12.5MG | SUPPOSITORY;RECTAL | Prescription | No | AB | 040428 | COSETTE |
PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | 12.5MG | SUPPOSITORY;RECTAL | Prescription | No | AB | 040500 | PERRIGO ISRAEL |
PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | 12.5MG | SUPPOSITORY;RECTAL | Prescription | No | AB | 040603 | TARO |
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