Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074559
Company: MYLAN TECHNOLOGIES
Company: MYLAN TECHNOLOGIES
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NITROGLYCERIN | NITROGLYCERIN | 0.6MG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | AB2 | No | No |
| NITROGLYCERIN | NITROGLYCERIN | 0.4MG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | AB2 | No | Yes |
| NITROGLYCERIN | NITROGLYCERIN | 0.2MG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | AB2 | No | No |
| NITROGLYCERIN | NITROGLYCERIN | 0.1MG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | AB2 | 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 |
|---|---|---|---|---|---|---|---|
| 08/30/1996 | 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 |
|---|---|---|---|---|---|
| 07/15/2002 | SUPPL-5 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 03/19/2001 | SUPPL-4 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 10/27/1999 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 12/22/1998 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 07/30/1997 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
NITROGLYCERIN
FILM, EXTENDED RELEASE;TRANSDERMAL; 0.6MG/HR
TE Code = AB2
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| NITROGLYCERIN | NITROGLYCERIN | 0.6MG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | No | AB2 | 074559 | MYLAN TECHNOLOGIES |
| NITROGLYCERIN | NITROGLYCERIN | 0.6MG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | No | AB2 | 089886 | ZYDUS PHARMS |
FILM, EXTENDED RELEASE;TRANSDERMAL; 0.4MG/HR
TE Code = AB2
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| NITROGLYCERIN | NITROGLYCERIN | 0.4MG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | No | AB2 | 074559 | MYLAN TECHNOLOGIES |
| NITROGLYCERIN | NITROGLYCERIN | 0.4MG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | No | AB2 | 089885 | ZYDUS PHARMS |
FILM, EXTENDED RELEASE;TRANSDERMAL; 0.2MG/HR
TE Code = AB2
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| NITROGLYCERIN | NITROGLYCERIN | 0.2MG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | No | AB2 | 074559 | MYLAN TECHNOLOGIES |
| NITROGLYCERIN | NITROGLYCERIN | 0.2MG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | No | AB2 | 089884 | ZYDUS PHARMS |
FILM, EXTENDED RELEASE;TRANSDERMAL; 0.1MG/HR
TE Code = AB2
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| NITROGLYCERIN | NITROGLYCERIN | 0.1MG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | No | AB2 | 074559 | MYLAN TECHNOLOGIES |
| NITROGLYCERIN | NITROGLYCERIN | 0.1MG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | No | AB2 | 089885 | ZYDUS PHARMS |