Drugs@FDA: FDA-Approved Drugs
Company: SUN PHARM INDUSTRIES
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PINDOLOL | PINDOLOL | 5MG | TABLET;ORAL | Prescription | AB | No | No |
PINDOLOL | PINDOLOL | 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 |
---|---|---|---|---|---|---|---|
01/27/1994 | 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 |
---|---|---|---|---|---|
03/09/2015 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
12/02/2002 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
02/15/2001 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
05/16/2000 | SUPPL-6 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
05/16/2000 | SUPPL-5 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
12/05/1997 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/24/1997 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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04/17/1996 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/22/1995 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
PINDOLOL
TABLET;ORAL; 5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
PINDOLOL | PINDOLOL | 5MG | TABLET;ORAL | Prescription | No | AB | 073609 | ANI PHARMS |
PINDOLOL | PINDOLOL | 5MG | TABLET;ORAL | Prescription | No | AB | 074019 | AUROBINDO PHARMA USA |
PINDOLOL | PINDOLOL | 5MG | TABLET;ORAL | Prescription | No | AB | 211712 | BAYSHORE PHARMS LLC |
PINDOLOL | PINDOLOL | 5MG | TABLET;ORAL | Prescription | No | AB | 205415 | NOSTRUM LABS INC |
PINDOLOL | PINDOLOL | 5MG | TABLET;ORAL | Prescription | No | AB | 074063 | SUN PHARM INDUSTRIES |
TABLET;ORAL; 10MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
PINDOLOL | PINDOLOL | 10MG | TABLET;ORAL | Prescription | No | AB | 073609 | ANI PHARMS |
PINDOLOL | PINDOLOL | 10MG | TABLET;ORAL | Prescription | No | AB | 074019 | AUROBINDO PHARMA USA |
PINDOLOL | PINDOLOL | 10MG | TABLET;ORAL | Prescription | No | AB | 211712 | BAYSHORE PHARMS LLC |
PINDOLOL | PINDOLOL | 10MG | TABLET;ORAL | Prescription | No | AB | 205415 | NOSTRUM LABS INC |
PINDOLOL | PINDOLOL | 10MG | TABLET;ORAL | Prescription | No | AB | 074063 | SUN PHARM INDUSTRIES |