Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065490
Company: STRIDES PHARMA
Company: STRIDES PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 125MG BASE | CAPSULE;ORAL | Prescription | AB | No | No |
VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 250MG 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 |
---|---|---|---|---|---|---|---|
04/09/2012 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/065490s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/06/2024 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
03/06/2024 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
03/06/2024 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
05/03/2019 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
VANCOMYCIN HYDROCHLORIDE
CAPSULE;ORAL; EQ 125MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
VANCOCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 125MG BASE | CAPSULE;ORAL | Prescription | Yes | AB | 050606 | ANI PHARMS |
VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 125MG BASE | CAPSULE;ORAL | Prescription | No | AB | 090439 | LUPIN LTD |
VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 125MG BASE | CAPSULE;ORAL | Prescription | No | AB | 210729 | ORIENT PHARMA CO LTD |
VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 125MG BASE | CAPSULE;ORAL | Prescription | No | AB | 065490 | STRIDES PHARMA |
CAPSULE;ORAL; EQ 250MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
VANCOCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 250MG BASE | CAPSULE;ORAL | Prescription | Yes | AB | 050606 | ANI PHARMS |
VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 250MG BASE | CAPSULE;ORAL | Prescription | No | AB | 090439 | LUPIN LTD |
VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 250MG BASE | CAPSULE;ORAL | Prescription | No | AB | 210729 | ORIENT PHARMA CO LTD |
VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 250MG BASE | CAPSULE;ORAL | Prescription | No | AB | 065490 | STRIDES PHARMA |