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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076642
Company: AMNEAL PHARMS NY
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROCODONE BITARTRATE AND IBUPROFEN HYDROCODONE BITARTRATE; IBUPROFEN 7.5MG;200MG TABLET;ORAL Prescription AB No Yes
HYDROCODONE BITARTRATE AND IBUPROFEN HYDROCODONE BITARTRATE; IBUPROFEN 5MG;200MG TABLET;ORAL Prescription AB No No
REPREXAIN HYDROCODONE BITARTRATE; IBUPROFEN 2.5MG;200MG TABLET;ORAL Discontinued None No No
REPREXAIN HYDROCODONE BITARTRATE; IBUPROFEN 10MG;200MG TABLET;ORAL Discontinued 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
03/18/2004 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076642_original_approval_pkg.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/28/2021 SUPPL-32 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

03/04/2021 SUPPL-30 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

10/10/2019 SUPPL-28 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

07/22/2019 SUPPL-27 Labeling-Package Insert

Label is not available on this site.

09/18/2018 SUPPL-25 REMS - PROPOSAL - D-N-A

Label is not available on this site.

09/21/2018 SUPPL-24 Labeling-Package Insert

Label is not available on this site.

08/15/2018 SUPPL-23 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

08/15/2018 SUPPL-22 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

08/15/2018 SUPPL-20 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

03/20/2008 SUPPL-11 Manufacturing (CMC)-Facility

Label is not available on this site.

01/04/2007 SUPPL-10 Labeling

Label is not available on this site.

01/03/2007 SUPPL-9 Labeling

Label is not available on this site.

10/19/2007 SUPPL-8 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/076642 s005ltr.pdf
10/19/2007 SUPPL-7 Manufacturing (CMC)-New Strength Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/076642 s005ltr.pdf
10/19/2007 SUPPL-6 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/076642 s005ltr.pdf
10/19/2007 SUPPL-5 Manufacturing (CMC)-New Strength Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/076642 s005ltr.pdf
10/12/2004 SUPPL-3

Label is not available on this site.

06/16/2004 SUPPL-2 Labeling

Label is not available on this site.

04/05/2004 SUPPL-1 Labeling

Label is not available on this site.

HYDROCODONE BITARTRATE AND IBUPROFEN

TABLET;ORAL; 7.5MG;200MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
HYDROCODONE BITARTRATE AND IBUPROFEN HYDROCODONE BITARTRATE; IBUPROFEN 7.5MG;200MG TABLET;ORAL Prescription No AB 076604 ACTAVIS LABS FL INC
HYDROCODONE BITARTRATE AND IBUPROFEN HYDROCODONE BITARTRATE; IBUPROFEN 7.5MG;200MG TABLET;ORAL Prescription No AB 076642 AMNEAL PHARMS NY
HYDROCODONE BITARTRATE AND IBUPROFEN HYDROCODONE BITARTRATE; IBUPROFEN 7.5MG;200MG TABLET;ORAL Prescription No AB 204575 AUROLIFE PHARMA LLC
HYDROCODONE BITARTRATE AND IBUPROFEN HYDROCODONE BITARTRATE; IBUPROFEN 7.5MG;200MG TABLET;ORAL Prescription No AB 077723 NOSTRUM LABS INC

TABLET;ORAL; 5MG;200MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
HYDROCODONE HYDROCODONE BITARTRATE; IBUPROFEN 5MG;200MG TABLET;ORAL Prescription No AB 077723 NOSTRUM LABS INC
HYDROCODONE BITARTRATE AND IBUPROFEN HYDROCODONE BITARTRATE; IBUPROFEN 5MG;200MG TABLET;ORAL Prescription No AB 076642 AMNEAL PHARMS NY

REPREXAIN

There are no Therapeutic Equivalents.

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