Drugs@FDA: FDA-Approved Drugs
Company: BARR
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MEDROXYPROGESTERONE ACETATE | MEDROXYPROGESTERONE ACETATE | 2.5MG | TABLET;ORAL | Prescription | AB | No | No |
MEDROXYPROGESTERONE ACETATE | MEDROXYPROGESTERONE ACETATE | 5MG | TABLET;ORAL | Prescription | AB | No | No |
MEDROXYPROGESTERONE ACETATE | MEDROXYPROGESTERONE ACETATE | 10MG | 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 |
---|---|---|---|---|---|---|---|
08/09/1996 | 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 |
---|---|---|---|---|---|
06/07/2021 | SUPPL-29 | Labeling-Patient Package Insert |
Label is not available on this site. |
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12/26/2007 | SUPPL-23 | Labeling |
Label is not available on this site. |
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04/10/2002 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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10/26/2001 | SUPPL-20 | Labeling |
Label is not available on this site. |
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12/14/2001 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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05/16/2000 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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09/24/1999 | SUPPL-17 | Labeling |
Label is not available on this site. |
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12/21/1999 | SUPPL-16 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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01/24/2000 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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07/07/1999 | SUPPL-14 | Labeling |
Label is not available on this site. |
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05/20/1999 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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03/26/1999 | SUPPL-12 | Labeling |
Label is not available on this site. |
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03/26/1999 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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02/05/1999 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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12/01/1998 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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03/11/1999 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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09/25/1998 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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09/25/1998 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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12/27/1996 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
MEDROXYPROGESTERONE ACETATE
TABLET;ORAL; 2.5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MEDROXYPROGESTERONE ACETATE | MEDROXYPROGESTERONE ACETATE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 040159 | BARR |
PROVERA | MEDROXYPROGESTERONE ACETATE | 2.5MG | TABLET;ORAL | Prescription | Yes | AB | 011839 | PFIZER |
TABLET;ORAL; 5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MEDROXYPROGESTERONE ACETATE | MEDROXYPROGESTERONE ACETATE | 5MG | TABLET;ORAL | Prescription | No | AB | 040159 | BARR |
PROVERA | MEDROXYPROGESTERONE ACETATE | 5MG | TABLET;ORAL | Prescription | Yes | AB | 011839 | PFIZER |
TABLET;ORAL; 10MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MEDROXYPROGESTERONE ACETATE | MEDROXYPROGESTERONE ACETATE | 10MG | TABLET;ORAL | Prescription | No | AB | 040159 | BARR |
PROVERA | MEDROXYPROGESTERONE ACETATE | 10MG | TABLET;ORAL | Prescription | Yes | AB | 011839 | PFIZER |