Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075072
Company: STRIDES PHARMA
Company: STRIDES PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | 240MG | TABLET, EXTENDED RELEASE;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 |
---|---|---|---|---|---|---|---|
05/25/1999 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/75072_Verapamil_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75072ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/75072_Verapamil.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/20/2002 | SUPPL-6 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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05/20/2002 | SUPPL-5 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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03/22/2002 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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08/21/2001 | SUPPL-3 | Labeling |
Label is not available on this site. |
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02/14/2001 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
06/24/1999 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
05/25/1999 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/75072_Verapamil_prntlbl.pdf |
VERAPAMIL HYDROCHLORIDE
TABLET, EXTENDED RELEASE;ORAL; 120MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 206173 | CADILA PHARMS LTD |
VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 090700 | GLENMARK PHARMS LTD |
VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 075072 | STRIDES PHARMA |
TABLET, EXTENDED RELEASE;ORAL; 240MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | 240MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 206173 | CADILA PHARMS LTD |
VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | 240MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078906 | GLENMARK PHARMS LTD |
VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | 240MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 075072 | STRIDES PHARMA |