Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075907
Company: PRINSTON INC
Company: PRINSTON INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE | 12.5MG | 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 |
---|---|---|---|---|---|---|---|
09/17/2002 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/075907.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/06/2022 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
07/07/2011 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
HYDROCHLOROTHIAZIDE
CAPSULE;ORAL; 12.5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE | 12.5MG | CAPSULE;ORAL | Prescription | No | AB | 078164 | AUROBINDO PHARMA |
HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE | 12.5MG | CAPSULE;ORAL | Prescription | No | AB | 079237 | IPCA LABS LTD |
HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE | 12.5MG | CAPSULE;ORAL | Prescription | No | AB | 078391 | JUBILANT CADISTA |
HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE | 12.5MG | CAPSULE;ORAL | Prescription | No | AB | 075907 | PRINSTON INC |
HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE | 12.5MG | CAPSULE;ORAL | Prescription | No | AB | 203561 | SCIEGEN PHARMS INC |
HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE | 12.5MG | CAPSULE;ORAL | Prescription | No | AB | 090510 | UNICHEM |
MICROZIDE | HYDROCHLOROTHIAZIDE | 12.5MG | CAPSULE;ORAL | Prescription | Yes | AB | 020504 | TEVA BRANDED PHARM |