Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 017558
Company: HIKMA
Company: HIKMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ROBINUL | GLYCOPYRROLATE | 0.2MG/ML | INJECTABLE;INJECTION | Prescription | AP | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 02/06/1975 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/017558_S000_RobinulTOC.html |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/25/2025 | SUPPL-69 | Manufacturing (CMC)-Packaging |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/017558Orig1s069lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/017558Orig1s069ltr.pdf | |
| 07/16/2025 | SUPPL-68 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/017558s068lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/017558Orig1s068ltr.pdf | |
| 02/24/2026 | SUPPL-66 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/017558s066lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/017558Orig1s066ltr.pdf | |
| 07/12/2024 | SUPPL-63 | Manufacturing (CMC)-Packaging |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/017558s063lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/017558Orig1s063ltr.pdf | |
| 07/05/2018 | SUPPL-62 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017558s062lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/017558Orig1s062ltr.pdf | |
| 03/18/2014 | SUPPL-60 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/26/2005 | SUPPL-53 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017558s053lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017558s053ltr.pdf | |
| 11/05/2004 | SUPPL-50 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17558s045,046,049,050ltr.pdf |
| 11/05/2004 | SUPPL-49 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17558s045,046,049,050ltr.pdf |
| 06/30/2003 | SUPPL-48 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17558slr047,048ltr.pdf |
| 06/30/2003 | SUPPL-47 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17558slr047,048ltr.pdf |
| 11/05/2004 | SUPPL-46 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17558s045,046,049,050ltr.pdf |
| 11/05/2004 | SUPPL-45 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17558s045,046,049,050ltr.pdf |
| 04/26/2001 | SUPPL-43 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/13/1998 | SUPPL-42 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/06/1988 | SUPPL-41 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 06/06/1988 | SUPPL-40 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/18/1988 | SUPPL-39 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/16/1987 | SUPPL-38 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/12/1986 | SUPPL-37 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/12/1986 | SUPPL-36 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/24/1986 | SUPPL-35 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/02/1983 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/02/1983 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/04/1982 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/19/1982 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/06/1981 | SUPPL-26 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 09/24/1981 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/22/1981 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 10/22/1981 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 10/22/1981 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/26/1980 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/04/1980 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 04/01/1980 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 04/01/1980 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/01/1980 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 04/01/1980 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/30/1978 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/17/1978 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 08/17/1978 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 04/25/1978 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 11/02/1976 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 09/22/1976 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/05/1975 | SUPPL-1 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 02/24/2026 | SUPPL-66 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/017558s066lbl.pdf | |
| 09/25/2025 | SUPPL-69 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/017558Orig1s069lbl.pdf | |
| 07/16/2025 | SUPPL-68 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/017558s068lbl.pdf | |
| 07/12/2024 | SUPPL-63 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/017558s063lbl.pdf | |
| 07/05/2018 | SUPPL-62 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017558s062lbl.pdf | |
| 05/26/2005 | SUPPL-53 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017558s053lbl.pdf |
ROBINUL
INJECTABLE;INJECTION; 0.2MG/ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| GLYCOPYRROLATE | GLYCOPYRROLATE | 0.2MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 213238 | ACCORD HLTHCARE |
| GLYCOPYRROLATE | GLYCOPYRROLATE | 0.2MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 214635 | ALEMBIC |
| GLYCOPYRROLATE | GLYCOPYRROLATE | 0.2MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 089335 | AM REGENT |
| GLYCOPYRROLATE | GLYCOPYRROLATE | 0.2MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 208973 | AMNEAL |
| GLYCOPYRROLATE | GLYCOPYRROLATE | 0.2MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 215333 | AMNEAL |
| GLYCOPYRROLATE | GLYCOPYRROLATE | 0.2MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 211705 | CAPLIN |
| GLYCOPYRROLATE | GLYCOPYRROLATE | 0.2MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 209024 | FRESENIUS KABI USA |
| GLYCOPYRROLATE | GLYCOPYRROLATE | 0.2MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 209328 | FRESENIUS KABI USA |
| GLYCOPYRROLATE | GLYCOPYRROLATE | 0.2MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 212612 | GLAND |
| GLYCOPYRROLATE | GLYCOPYRROLATE | 0.2MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 090963 | HIKMA FARMACEUTICA |
| GLYCOPYRROLATE | GLYCOPYRROLATE | 0.2MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 212802 | MEITHEAL |
| GLYCOPYRROLATE | GLYCOPYRROLATE | 0.2MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 212591 | NIVAGEN PHARMS INC |
| GLYCOPYRROLATE | GLYCOPYRROLATE | 0.2MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 212871 | OMNIVIUM PHARMS |
| GLYCOPYRROLATE | GLYCOPYRROLATE | 0.2MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 210842 | PIRAMAL CRITICAL |
| GLYCOPYRROLATE | GLYCOPYRROLATE | 0.2MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 210927 | PRINSTON INC |
| GLYCOPYRROLATE | GLYCOPYRROLATE | 0.2MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 210083 | SAGENT |
| GLYCOPYRROLATE | GLYCOPYRROLATE | 0.2MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 211334 | SANDOZ |
| GLYCOPYRROLATE | GLYCOPYRROLATE | 0.2MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 207639 | SOMERSET THERAPS LLC |
| ROBINUL | GLYCOPYRROLATE | 0.2MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 017558 | HIKMA |