Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 086831
Company: MYLAN
Company: MYLAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CHLORTHALIDONE | CHLORTHALIDONE | 50MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
| CHLORTHALIDONE | CHLORTHALIDONE | 25MG | 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 |
|---|---|---|---|---|---|---|---|
| 02/26/1981 | 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 |
|---|---|---|---|---|---|
| 08/22/2002 | SUPPL-31 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
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| 12/10/1999 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/25/1998 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/05/1998 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/20/1993 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/21/1993 | SUPPL-26 | Labeling |
Label is not available on this site. |
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| 01/13/1992 | SUPPL-24 | Labeling |
Label is not available on this site. |
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| 09/20/1991 | SUPPL-23 | Labeling |
Label is not available on this site. |
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| 01/31/1990 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/19/1989 | SUPPL-21 | Labeling |
Label is not available on this site. |
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| 03/29/1988 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/19/1987 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/15/1985 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/24/1984 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/24/1982 | SUPPL-1 | Manufacturing (CMC) |
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 |