Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077458
Company: WEST-WARD PHARMS INT
Company: WEST-WARD PHARMS INT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
RANITIDINE HYDROCHLORIDE | RANITIDINE HYDROCHLORIDE | EQ 25MG BASE/ML | INJECTABLE;INJECTION | Prescription | AP | 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 |
---|---|---|---|---|---|---|---|
02/16/2006 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/77458ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/29/2010 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
06/18/2009 | SUPPL-1 | Labeling |
Label is not available on this site. |
RANITIDINE HYDROCHLORIDE
INJECTABLE;INJECTION; EQ 25MG BASE/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
RANITIDINE HYDROCHLORIDE | RANITIDINE HYDROCHLORIDE | EQ 25MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 079076 | MYLAN LABS LTD |
RANITIDINE HYDROCHLORIDE | RANITIDINE HYDROCHLORIDE | EQ 25MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 074777 | WEST-WARD PHARMS INT |
RANITIDINE HYDROCHLORIDE | RANITIDINE HYDROCHLORIDE | EQ 25MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 077458 | WEST-WARD PHARMS INT |
RANITIDINE HYDROCHLORIDE | RANITIDINE HYDROCHLORIDE | EQ 25MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 091534 | ZYDUS PHARMS USA INC |
ZANTAC | RANITIDINE HYDROCHLORIDE | EQ 25MG BASE/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 019090 | TELIGENT |
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