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Abbreviated New Drug Application (ANDA): 075347
Company: ACTAVIS LABS FL INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OMEPRAZOLE OMEPRAZOLE 10MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription AB No No
OMEPRAZOLE OMEPRAZOLE 20MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription AB No No
OMEPRAZOLE OMEPRAZOLE 40MG CAPSULE, DELAYED REL PELLETS;ORAL 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
05/30/2008 ORIG-1 Approval Letter (PDF)
Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75347ta.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75347ltr.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/075347.PDF
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/04/2022 SUPPL-29 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

11/27/2020 SUPPL-27 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

06/07/2018 SUPPL-24 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

05/31/2018 SUPPL-23 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

05/31/2018 SUPPL-22 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

04/01/2015 SUPPL-20 Labeling-Package Insert

Label is not available on this site.

04/01/2015 SUPPL-18 Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

09/17/2012 SUPPL-14 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

03/09/2012 SUPPL-13 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

03/09/2012 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

03/09/2012 SUPPL-7 Labeling

Label is not available on this site.

10/04/2002 SUPPL-5 Labeling

Label is not available on this site.

10/04/2002 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/24/2002 SUPPL-2 Manufacturing (CMC)-Facility

Label is not available on this site.

07/31/2002 SUPPL-1 Manufacturing (CMC)-Facility

Label is not available on this site.

OMEPRAZOLE

CAPSULE, DELAYED REL PELLETS;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OMEPRAZOLE OMEPRAZOLE 10MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 075347 ACTAVIS LABS FL INC
OMEPRAZOLE OMEPRAZOLE 10MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 076048 APOTEX
OMEPRAZOLE OMEPRAZOLE 10MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 203270 AUROBINDO PHARMA
OMEPRAZOLE OMEPRAZOLE 10MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 203481 BRECKENRIDGE
OMEPRAZOLE OMEPRAZOLE 10MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 075576 DR REDDYS LABS LTD
OMEPRAZOLE OMEPRAZOLE 10MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 078490 DR REDDYS LABS LTD
OMEPRAZOLE OMEPRAZOLE 10MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 091672 GLENMARK GENERICS
OMEPRAZOLE OMEPRAZOLE 10MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 204012 HETERO LABS LTD III
OMEPRAZOLE OMEPRAZOLE 10MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 075785 IMPAX LABS
OMEPRAZOLE OMEPRAZOLE 10MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 075410 LANNETT CO INC
OMEPRAZOLE OMEPRAZOLE 10MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 075757 SANDOZ
OMEPRAZOLE OMEPRAZOLE 10MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 212977 XIROMED
OMEPRAZOLE OMEPRAZOLE 10MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 091352 ZYDUS PHARMS USA INC

CAPSULE, DELAYED REL PELLETS;ORAL; 20MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OMEPRAZOLE OMEPRAZOLE 20MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 075347 ACTAVIS LABS FL INC
OMEPRAZOLE OMEPRAZOLE 20MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 076048 APOTEX
OMEPRAZOLE OMEPRAZOLE 20MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 203270 AUROBINDO PHARMA
OMEPRAZOLE OMEPRAZOLE 20MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 203481 BRECKENRIDGE
OMEPRAZOLE OMEPRAZOLE 20MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 075576 DR REDDYS LABS LTD
OMEPRAZOLE OMEPRAZOLE 20MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 078490 DR REDDYS LABS LTD
OMEPRAZOLE OMEPRAZOLE 20MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 091672 GLENMARK GENERICS
OMEPRAZOLE OMEPRAZOLE 20MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 204012 HETERO LABS LTD III
OMEPRAZOLE OMEPRAZOLE 20MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 075785 IMPAX LABS
OMEPRAZOLE OMEPRAZOLE 20MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 075410 LANNETT CO INC
OMEPRAZOLE OMEPRAZOLE 20MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 075757 SANDOZ
OMEPRAZOLE OMEPRAZOLE 20MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 204661 TEVA PHARMS USA
OMEPRAZOLE OMEPRAZOLE 20MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 212977 XIROMED
OMEPRAZOLE OMEPRAZOLE 20MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 091352 ZYDUS PHARMS USA INC

CAPSULE, DELAYED REL PELLETS;ORAL; 40MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OMEPRAZOLE OMEPRAZOLE 40MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 075347 ACTAVIS LABS FL INC
OMEPRAZOLE OMEPRAZOLE 40MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 076048 APOTEX
OMEPRAZOLE OMEPRAZOLE 40MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 203270 AUROBINDO PHARMA
OMEPRAZOLE OMEPRAZOLE 40MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 203481 BRECKENRIDGE
OMEPRAZOLE OMEPRAZOLE 40MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 075576 DR REDDYS LABS LTD
OMEPRAZOLE OMEPRAZOLE 40MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 078490 DR REDDYS LABS LTD
OMEPRAZOLE OMEPRAZOLE 40MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 091672 GLENMARK GENERICS
OMEPRAZOLE OMEPRAZOLE 40MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 075785 IMPAX LABS
OMEPRAZOLE OMEPRAZOLE 40MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 075410 LANNETT CO INC
OMEPRAZOLE OMEPRAZOLE 40MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 076515 SANDOZ
OMEPRAZOLE OMEPRAZOLE 40MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 091352 ZYDUS PHARMS USA INC
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