Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 062337
Company: STRIDES PHARMA
Company: STRIDES PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 50MG BASE | CAPSULE;ORAL | Prescription | AB | No | No |
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 100MG BASE | 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 |
|---|---|---|---|---|---|---|---|
| 03/29/1982 | 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 |
|---|---|---|---|---|---|
| 03/31/2025 | SUPPL-39 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/25/2025 | SUPPL-38 | Labeling-Package Insert |
Label is not available on this site. |
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| 03/25/2025 | SUPPL-35 | Labeling-Package Insert |
Label is not available on this site. |
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| 03/25/2025 | SUPPL-33 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/25/2025 | SUPPL-31 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/25/2025 | SUPPL-30 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/25/2025 | SUPPL-27 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/30/2015 | SUPPL-25 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/02/2014 | SUPPL-24 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/23/2002 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 02/05/1998 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/25/1998 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/22/1993 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/22/1993 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/01/1993 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 12/16/1992 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 05/12/1992 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 05/12/1992 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 01/31/1990 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/31/1990 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/25/1989 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
DOXYCYCLINE HYCLATE
CAPSULE;ORAL; EQ 50MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 50MG BASE | CAPSULE;ORAL | Prescription | No | AB | 062031 | ACTAVIS LABS FL INC |
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 50MG BASE | CAPSULE;ORAL | Prescription | No | AB | 210527 | ALEMBIC |
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 50MG BASE | CAPSULE;ORAL | Prescription | No | AB | 062500 | CHARTWELL |
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 50MG BASE | CAPSULE;ORAL | Prescription | No | AB | 062396 | HIKMA INTL PHARMS |
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 50MG BASE | CAPSULE;ORAL | Prescription | No | AB | 062337 | STRIDES PHARMA |
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 50MG BASE | CAPSULE;ORAL | Prescription | No | AB | 062676 | SUN PHARM INDUSTRIES |
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 50MG BASE | CAPSULE;ORAL | Prescription | No | AB | 207774 | ZYDUS LIFESCIENCES |
CAPSULE;ORAL; EQ 100MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 100MG BASE | CAPSULE;ORAL | Prescription | No | AB | 062031 | ACTAVIS LABS FL INC |
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 100MG BASE | CAPSULE;ORAL | Prescription | No | AB | 210527 | ALEMBIC |
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 100MG BASE | CAPSULE;ORAL | Prescription | No | AB | 207289 | AMNEAL PHARMS |
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 100MG BASE | CAPSULE;ORAL | Prescription | No | AB | 209402 | CHANGZHOU PHARM |
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 100MG BASE | CAPSULE;ORAL | Prescription | No | AB | 062500 | CHARTWELL |
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 100MG BASE | CAPSULE;ORAL | Prescription | No | AB | 062396 | HIKMA INTL PHARMS |
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 100MG BASE | CAPSULE;ORAL | Prescription | No | AB | 211137 | MACLEODS PHARMS LTD |
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 100MG BASE | CAPSULE;ORAL | Prescription | No | AB | 062337 | STRIDES PHARMA |
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 100MG BASE | CAPSULE;ORAL | Prescription | No | AB | 062676 | SUN PHARM INDUSTRIES |
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 100MG BASE | CAPSULE;ORAL | Prescription | No | AB | 207774 | ZYDUS LIFESCIENCES |