Drugs@FDA: FDA-Approved Drugs
Company: NOVITIUM PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PYRAZINAMIDE | PYRAZINAMIDE | 500MG | TABLET;ORAL | Prescription | AB | Yes | 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 |
---|---|---|---|---|---|---|---|
06/03/1971 | 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 |
---|---|---|---|---|---|
02/28/2001 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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02/28/2001 | SUPPL-17 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
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02/28/2001 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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03/03/1999 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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05/23/1994 | SUPPL-14 | Labeling |
Label is not available on this site. |
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05/16/1994 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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04/20/1992 | SUPPL-11 | Labeling |
Label is not available on this site. |
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10/22/1991 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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10/04/1990 | SUPPL-9 | Labeling |
Label is not available on this site. |
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10/19/1987 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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08/10/1982 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
PYRAZINAMIDE
TABLET;ORAL; 500MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
PYRAZINAMIDE | PYRAZINAMIDE | 500MG | TABLET;ORAL | Prescription | No | AB | 081319 | HIKMA |
PYRAZINAMIDE | PYRAZINAMIDE | 500MG | TABLET;ORAL | Prescription | No | AB | 212541 | MACLEODS PHARMS LTD |
PYRAZINAMIDE | PYRAZINAMIDE | 500MG | TABLET;ORAL | Prescription | Yes | AB | 080157 | NOVITIUM PHARMA |