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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 071026
Company: TP ANDA HOLDINGS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OXAZEPAM OXAZEPAM 30MG CAPSULE;ORAL Prescription AB No No
OXAZEPAM OXAZEPAM 10MG CAPSULE;ORAL Prescription AB No No
OXAZEPAM OXAZEPAM 15MG CAPSULE;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
08/10/1987 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
01/17/2023 SUPPL-21 Labeling-Package Insert

Label is not available on this site.
02/05/2021 SUPPL-20 Labeling-Package Insert

Label is not available on this site.
03/17/2020 SUPPL-18 Labeling-Package Insert

Label is not available on this site.
12/16/2016 SUPPL-17 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
12/01/1998 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.
12/23/1994 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.
10/05/1993 SUPPL-9 Labeling

Label is not available on this site.
04/03/1992 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.
04/03/1992 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.
04/19/1989 SUPPL-5 Labeling

Label is not available on this site.
01/25/1988 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.
01/25/1988 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.
01/25/1988 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

OXAZEPAM

CAPSULE;ORAL; 30MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OXAZEPAM OXAZEPAM 30MG CAPSULE;ORAL Prescription No AB 072253 ACTAVIS ELIZABETH
OXAZEPAM OXAZEPAM 30MG CAPSULE;ORAL Prescription No AB 071756 EPIC PHARMA LLC
OXAZEPAM OXAZEPAM 30MG CAPSULE;ORAL Prescription No AB 218261 LEADING
OXAZEPAM OXAZEPAM 30MG CAPSULE;ORAL Prescription No AB 071026 TP ANDA HOLDINGS

CAPSULE;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OXAZEPAM OXAZEPAM 10MG CAPSULE;ORAL Prescription No AB 072253 ACTAVIS ELIZABETH
OXAZEPAM OXAZEPAM 10MG CAPSULE;ORAL Prescription No AB 071756 EPIC PHARMA LLC
OXAZEPAM OXAZEPAM 10MG CAPSULE;ORAL Prescription No AB 218261 LEADING
OXAZEPAM OXAZEPAM 10MG CAPSULE;ORAL Prescription No AB 071026 TP ANDA HOLDINGS

CAPSULE;ORAL; 15MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OXAZEPAM OXAZEPAM 15MG CAPSULE;ORAL Prescription No AB 072253 ACTAVIS ELIZABETH
OXAZEPAM OXAZEPAM 15MG CAPSULE;ORAL Prescription No AB 071756 EPIC PHARMA LLC
OXAZEPAM OXAZEPAM 15MG CAPSULE;ORAL Prescription No AB 218261 LEADING
OXAZEPAM OXAZEPAM 15MG CAPSULE;ORAL Prescription No AB 071026 TP ANDA HOLDINGS
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