Drugs@FDA: FDA-Approved Drugs
Company: AM REGENT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
GLYCOPYRROLATE | GLYCOPYRROLATE | 0.2MG/ML | INJECTABLE;INJECTION | Prescription | AP | 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 |
---|---|---|---|---|---|---|---|
07/23/1986 | 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 |
---|---|---|---|---|---|
09/04/2019 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
||
09/26/2006 | SUPPL-15 | Labeling |
Label is not available on this site. |
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06/23/1997 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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02/28/1996 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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05/09/1991 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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03/15/1990 | SUPPL-7 | Labeling |
Label is not available on this site. |
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01/25/1990 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
03/04/1991 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/09/1991 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/09/1991 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/08/1988 | SUPPL-2 | Labeling |
Label is not available on this site. |
GLYCOPYRROLATE
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 | 210246 | APOTEX |
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 PHARMA LTD |
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 | 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 |
GLYCOPYRROLATE | GLYCOPYRROLATE | 0.2MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 212591 | UMEDICA |
GLYCOPYRROLATE | GLYCOPYRROLATE | 0.2MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 212227 | XIROMED |