Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090180
Company: NOSTRUM LABS INC
Company: NOSTRUM LABS INC
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 |
PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE | PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE | 10MG; 5ML | SYRUP; ORAL | Prescription | None | 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 |
---|---|---|---|---|---|---|---|
03/17/2010 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090180s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/28/2018 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
08/29/2017 | SUPPL-7 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
01/13/2017 | SUPPL-6 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
05/10/2013 | SUPPL-5 | Labeling-Package Insert |
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 | 040151 | AKORN |
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 |
PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE
There are no Therapeutic Equivalents.
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