Drugs@FDA: FDA-Approved Drugs
Company: MMT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ATROPEN | ATROPINE | EQ 2MG SULFATE/0.7ML | SOLUTION;INTRAMUSCULAR | Prescription | None | Yes | Yes |
| ATROPEN | ATROPINE | EQ 1MG SULFATE/0.7ML | SOLUTION;INTRAMUSCULAR | Prescription | None | Yes | Yes |
| ATROPEN | ATROPINE | EQ 0.5MG SULFATE/0.7ML | SOLUTION;INTRAMUSCULAR | Prescription | None | Yes | Yes |
| ATROPEN | ATROPINE | EQ 0.25MG SULFATE/0.3ML | SOLUTION;INTRAMUSCULAR | Prescription | None | 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 |
|---|---|---|---|---|---|---|---|
| 05/15/1973 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | PRIORITY |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/20/2020 | SUPPL-52 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/017106s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/017106Orig1s052ltr.pdf | |
| 08/10/2015 | SUPPL-51 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/27/2016 | SUPPL-49 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/14/2013 | SUPPL-45 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/17/2004 | SUPPL-32 | Manufacturing (CMC)-Formulation |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17106s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17106s032ltr.pdf | |
| 06/19/2003 | SUPPL-28 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/17106se5-028_atroPen_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17106se5-028ltr.pdf | |
| 06/28/2002 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/07/2002 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/04/2002 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/08/2001 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/13/2001 | SUPPL-23 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/31/2001 | SUPPL-22 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/19/2000 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/16/2000 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/18/2000 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/28/1999 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/26/1999 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/16/1999 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/25/1998 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/21/1998 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 03/06/1997 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/17/1996 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/05/1991 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/17/1990 | SUPPL-10 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/04/1989 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/19/1987 | SUPPL-8 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/06/1986 | SUPPL-7 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/14/1985 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/06/1984 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 12/27/1979 | SUPPL-4 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 05/10/1979 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/27/1978 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/20/2020 | SUPPL-52 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/017106s052lbl.pdf | |
| 11/20/2020 | SUPPL-52 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/017106s052lbl.pdf | |
| 09/17/2004 | SUPPL-32 | Manufacturing (CMC)-Formulation | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17106s032lbl.pdf | |
| 06/19/2003 | SUPPL-28 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/17106se5-028_atroPen_lbl.pdf |