Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 089286
Company: SUN PHARM INDUSTRIES
Company: SUN PHARM INDUSTRIES
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CHLORTHALIDONE | CHLORTHALIDONE | 50MG | TABLET;ORAL | Prescription | AB | No | No |
| CHLORTHALIDONE | CHLORTHALIDONE | 25MG | 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 |
|---|---|---|---|---|---|---|---|
| 07/21/1986 | 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 |
|---|---|---|---|---|---|
| 11/08/2002 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 07/29/2002 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 05/16/2000 | SUPPL-12 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 05/16/2000 | SUPPL-11 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 12/05/1997 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/24/1997 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/08/1996 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/15/1997 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/29/1996 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 06/22/1995 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/12/1994 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/01/1991 | SUPPL-3 | Labeling |
Label is not available on this site. |
CHLORTHALIDONE
TABLET;ORAL; 50MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CHLORTHALIDONE | CHLORTHALIDONE | 50MG | TABLET;ORAL | Prescription | No | AB | 214129 | AJANTA PHARMA LTD |
| CHLORTHALIDONE | CHLORTHALIDONE | 50MG | TABLET;ORAL | Prescription | No | AB | 216262 | ALEMBIC |
| CHLORTHALIDONE | CHLORTHALIDONE | 50MG | TABLET;ORAL | Prescription | No | AB | 213412 | ALKEM LABS LTD |
| CHLORTHALIDONE | CHLORTHALIDONE | 50MG | TABLET;ORAL | Prescription | No | AB | 207204 | AMNEAL PHARMS CO |
| CHLORTHALIDONE | CHLORTHALIDONE | 50MG | TABLET;ORAL | Prescription | No | AB | 210742 | APPCO |
| CHLORTHALIDONE | CHLORTHALIDONE | 50MG | TABLET;ORAL | Prescription | No | AB | 211063 | CHARTWELL RX |
| CHLORTHALIDONE | CHLORTHALIDONE | 50MG | TABLET;ORAL | Prescription | No | AB | 211320 | INVENTIA |
| CHLORTHALIDONE | CHLORTHALIDONE | 50MG | TABLET;ORAL | Prescription | No | AB | 215587 | MANKIND PHARMA |
| CHLORTHALIDONE | CHLORTHALIDONE | 50MG | TABLET;ORAL | Prescription | Yes | AB | 086831 | MYLAN |
| CHLORTHALIDONE | CHLORTHALIDONE | 50MG | TABLET;ORAL | Prescription | No | AB | 206904 | NOVAST LABS |
| CHLORTHALIDONE | CHLORTHALIDONE | 50MG | TABLET;ORAL | Prescription | No | AB | 089286 | SUN PHARM INDUSTRIES |
| CHLORTHALIDONE | CHLORTHALIDONE | 50MG | TABLET;ORAL | Prescription | No | AB | 212875 | TAGI |
| CHLORTHALIDONE | CHLORTHALIDONE | 50MG | TABLET;ORAL | Prescription | No | AB | 207222 | UMEDICA |
| CHLORTHALIDONE | CHLORTHALIDONE | 50MG | TABLET;ORAL | Prescription | No | AB | 211627 | UNICHEM |
| CHLORTHALIDONE | CHLORTHALIDONE | 50MG | TABLET;ORAL | Prescription | No | AB | 207813 | ZYDUS PHARMS |
TABLET;ORAL; 25MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CHLORTHALIDONE | CHLORTHALIDONE | 25MG | TABLET;ORAL | Prescription | No | AB | 214129 | AJANTA PHARMA LTD |
| CHLORTHALIDONE | CHLORTHALIDONE | 25MG | TABLET;ORAL | Prescription | No | AB | 216262 | ALEMBIC |
| CHLORTHALIDONE | CHLORTHALIDONE | 25MG | TABLET;ORAL | Prescription | No | AB | 213412 | ALKEM LABS LTD |
| CHLORTHALIDONE | CHLORTHALIDONE | 25MG | TABLET;ORAL | Prescription | No | AB | 207204 | AMNEAL PHARMS CO |
| CHLORTHALIDONE | CHLORTHALIDONE | 25MG | TABLET;ORAL | Prescription | No | AB | 210742 | APPCO |
| CHLORTHALIDONE | CHLORTHALIDONE | 25MG | TABLET;ORAL | Prescription | No | AB | 211063 | CHARTWELL RX |
| CHLORTHALIDONE | CHLORTHALIDONE | 25MG | TABLET;ORAL | Prescription | No | AB | 211320 | INVENTIA |
| CHLORTHALIDONE | CHLORTHALIDONE | 25MG | TABLET;ORAL | Prescription | No | AB | 215587 | MANKIND PHARMA |
| CHLORTHALIDONE | CHLORTHALIDONE | 25MG | TABLET;ORAL | Prescription | Yes | AB | 086831 | MYLAN |
| CHLORTHALIDONE | CHLORTHALIDONE | 25MG | TABLET;ORAL | Prescription | No | AB | 206904 | NOVAST LABS |
| CHLORTHALIDONE | CHLORTHALIDONE | 25MG | TABLET;ORAL | Prescription | No | AB | 089286 | SUN PHARM INDUSTRIES |
| CHLORTHALIDONE | CHLORTHALIDONE | 25MG | TABLET;ORAL | Prescription | No | AB | 212878 | TAGI |
| CHLORTHALIDONE | CHLORTHALIDONE | 25MG | TABLET;ORAL | Prescription | No | AB | 207222 | UMEDICA |
| CHLORTHALIDONE | CHLORTHALIDONE | 25MG | TABLET;ORAL | Prescription | No | AB | 211627 | UNICHEM |
| CHLORTHALIDONE | CHLORTHALIDONE | 25MG | TABLET;ORAL | Prescription | No | AB | 207813 | ZYDUS PHARMS |