Drugs@FDA: FDA-Approved Drugs
Company: STRIDES PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;30MG | TABLET;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 |
---|---|---|---|---|---|---|---|
09/30/1988 | 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 |
---|---|---|---|---|---|
10/31/2024 | SUPPL-41 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
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12/15/2023 | SUPPL-39 | Labeling-Package Insert |
Label is not available on this site. |
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03/04/2021 | SUPPL-38 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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10/07/2019 | SUPPL-36 | Labeling-Package Insert |
Label is not available on this site. |
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10/07/2019 | SUPPL-35 | Labeling-Package Insert |
Label is not available on this site. |
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09/21/2018 | SUPPL-32 | Labeling-Package Insert |
Label is not available on this site. |
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09/18/2018 | SUPPL-31 | REMS - PROPOSAL - D-N-A |
Label is not available on this site. |
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08/29/2017 | SUPPL-29 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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12/16/2016 | SUPPL-27 | Labeling-Medication Guide, Labeling-Package Insert, Labeling-Package Insert |
Label is not available on this site. |
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12/16/2016 | SUPPL-26 | Labeling-Medication Guide, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
12/16/2016 | SUPPL-24 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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10/18/2013 | SUPPL-20 | Labeling-Package Insert |
Label is not available on this site. |
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05/10/2013 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
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06/22/2011 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
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02/11/2008 | SUPPL-12 | Labeling |
Label is not available on this site. |
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10/18/2007 | SUPPL-10 | Labeling |
Label is not available on this site. |
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01/10/2007 | SUPPL-7 | Labeling |
Label is not available on this site. |
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03/16/1995 | SUPPL-3 | Labeling |
Label is not available on this site. |
ACETAMINOPHEN AND CODEINE PHOSPHATE
TABLET;ORAL; 300MG;30MG
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;30MG | TABLET;ORAL | Prescription | No | AA | 040779 | AMNEAL PHARMS NY |
ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;30MG | TABLET;ORAL | Prescription | No | AA | 202800 | AUROLIFE PHARMA LLC |
ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;30MG | TABLET;ORAL | Prescription | No | AA | 212418 | ELITE LABS INC |
ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;30MG | TABLET;ORAL | Prescription | No | AA | 040419 | SPECGX LLC |
ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;30MG | TABLET;ORAL | Prescription | No | AA | 089805 | STRIDES PHARMA |
ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;30MG | TABLET;ORAL | Prescription | No | AA | 211610 | WES PHARMA INC |