اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است
COGENTIN از شرکت AKORN
New Drug Application (NDA): 012015
Company: AKORN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| COGENTIN | BENZTROPINE MESYLATE | 1MG/ML | INJECTABLE;INJECTION | Prescription |
AP |
Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 12/21/1959 | ORIG-1 | Approval |
Type 3 – New Dosage Form |
STANDARD |
|
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/03/2015 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/26/2013 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/22/2013 | SUPPL-27 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012015s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/12015Orig1s026,s027ltr.pdf |
||
| 04/22/2013 | SUPPL-26 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012015s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/12015Orig1s026,s027ltr.pdf |
||
| 07/27/1998 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/24/1998 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/22/2001 | SUPPL-23 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/12015s23ltr.pdf |
|
| 04/15/1996 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/26/1996 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 10/31/1988 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/14/1986 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 11/02/1981 | SUPPL-16 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/19/1981 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/14/1981 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/19/1979 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 05/05/1977 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 01/15/1975 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 07/01/1974 | SUPPL-6 | Unspecified |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/22/2013 | SUPPL-27 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012015s027lbl.pdf | |
| 04/22/2013 | SUPPL-26 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012015s026lbl.pdf |
COGENTIN
INJECTABLE;INJECTION; 1MG/ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 090233 | FRESENIUS KABI USA |
| BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 090287 | HIKMA FARMACEUTICA |
| BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 091525 | NAVINTA LLC |
| COGENTIN | BENZTROPINE MESYLATE | 1MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 012015 | AKORN |
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