Drugs@FDA: FDA-Approved Drugs
Company: TEVA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
GLYBURIDE (MICRONIZED) | GLYBURIDE | 1.5MG | TABLET;ORAL | Prescription | AB | No | No |
GLYBURIDE (MICRONIZED) | GLYBURIDE | 3MG | TABLET;ORAL | Prescription | AB | No | No |
GLYBURIDE (MICRONIZED) | GLYBURIDE | 4.5MG | TABLET;ORAL | Prescription | None | No | No |
GLYBURIDE (MICRONIZED) | GLYBURIDE | 6MG | TABLET;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 |
---|---|---|---|---|---|---|---|
04/20/1999 | ORIG-1 | Approval |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/74686ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/074686_ORIGINAL APPROVAL_PACKAGE.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/30/2019 | SUPPL-28 | Labeling-Package Insert |
Label is not available on this site. |
||
09/02/2015 | SUPPL-27 | Labeling-Package Insert |
Label is not available on this site. |
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03/24/2014 | SUPPL-25 | Labeling-Package Insert |
Label is not available on this site. |
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08/18/2011 | SUPPL-20 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
04/28/2010 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
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05/06/2009 | SUPPL-18 | Labeling |
Label is not available on this site. |
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05/06/2009 | SUPPL-17 | Labeling |
Label is not available on this site. |
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10/02/2002 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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10/02/2002 | SUPPL-9 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
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10/02/2002 | SUPPL-8 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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07/01/2002 | SUPPL-7 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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09/13/2000 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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02/15/2000 | SUPPL-5 | Labeling |
Label is not available on this site. |
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08/28/2000 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
08/28/2000 | SUPPL-3 | Labeling |
Label is not available on this site. |
GLYBURIDE (MICRONIZED)
TABLET;ORAL; 1.5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
GLYBURIDE (MICRONIZED) | GLYBURIDE | 1.5MG | TABLET;ORAL | Prescription | No | AB | 074686 | TEVA |
GLYNASE | GLYBURIDE | 1.5MG | TABLET;ORAL | Prescription | Yes | AB | 020051 | PFIZER |
TABLET;ORAL; 3MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
GLYBURIDE (MICRONIZED) | GLYBURIDE | 3MG | TABLET;ORAL | Prescription | No | AB | 074686 | TEVA |
GLYNASE | GLYBURIDE | 3MG | TABLET;ORAL | Prescription | Yes | AB | 020051 | PFIZER |
TABLET;ORAL; 6MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
GLYBURIDE (MICRONIZED) | GLYBURIDE | 6MG | TABLET;ORAL | Prescription | No | AB | 074686 | TEVA |
GLYNASE | GLYBURIDE | 6MG | TABLET;ORAL | Prescription | Yes | AB | 020051 | PFIZER |