Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065005
Company: IMPAX LABS
Company: IMPAX LABS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 50MG BASE | CAPSULE;ORAL | Prescription | AB | No | No |
MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 100MG BASE | CAPSULE;ORAL | Prescription | AB | No | No |
MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 75MG 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 |
---|---|---|---|---|---|---|---|
03/23/1999 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/65-005_Minocycline%20Hydrochloride_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/65005ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/65-005_Minocycline.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/15/2011 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
04/19/2004 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
04/13/2004 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
12/06/2001 | SUPPL-4 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
04/18/2001 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
04/18/2001 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
04/18/2001 | SUPPL-1 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
03/23/1999 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/65-005_Minocycline%20Hydrochloride_prntlbl.pdf |
MINOCYCLINE HYDROCHLORIDE
CAPSULE;ORAL; EQ 50MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MINOCIN | MINOCYCLINE HYDROCHLORIDE | EQ 50MG BASE | CAPSULE;ORAL | Prescription | Yes | AB | 050649 | BAUSCH |
MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 50MG BASE | CAPSULE;ORAL | Prescription | No | AB | 065470 | AUROBINDO PHARMA |
MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 50MG BASE | CAPSULE;ORAL | Prescription | No | AB | 065005 | IMPAX LABS |
MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 50MG BASE | CAPSULE;ORAL | Prescription | No | AB | 090867 | SUN PHARM INDS INC |
MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 50MG BASE | CAPSULE;ORAL | Prescription | No | AB | 065062 | TORRENT |
MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 50MG BASE | CAPSULE;ORAL | Prescription | No | AB | 063181 | WATSON LABS TEVA |
MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 50MG BASE | CAPSULE;ORAL | Prescription | No | AB | 063011 | ZYDUS |
CAPSULE;ORAL; EQ 100MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MINOCIN | MINOCYCLINE HYDROCHLORIDE | EQ 100MG BASE | CAPSULE;ORAL | Prescription | Yes | AB | 050649 | BAUSCH |
MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 100MG BASE | CAPSULE;ORAL | Prescription | No | AB | 065470 | AUROBINDO PHARMA |
MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 100MG BASE | CAPSULE;ORAL | Prescription | No | AB | 065005 | IMPAX LABS |
MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 100MG BASE | CAPSULE;ORAL | Prescription | No | AB | 090867 | SUN PHARM INDS INC |
MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 100MG BASE | CAPSULE;ORAL | Prescription | No | AB | 065062 | TORRENT |
MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 100MG BASE | CAPSULE;ORAL | Prescription | No | AB | 063065 | WATSON LABS |
MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 100MG BASE | CAPSULE;ORAL | Prescription | No | AB | 063009 | ZYDUS |
CAPSULE;ORAL; EQ 75MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE;ORAL | Prescription | No | AB | 065470 | AUROBINDO PHARMA |
MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE;ORAL | Prescription | No | AB | 065005 | IMPAX LABS |
MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE;ORAL | Prescription | No | AB | 090867 | SUN PHARM INDS INC |
MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE;ORAL | Prescription | No | AB | 065062 | TORRENT |
MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE;ORAL | Prescription | No | AB | 063065 | WATSON LABS |
MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE;ORAL | Prescription | No | AB | 063009 | ZYDUS |