Drugs@FDA: FDA-Approved Drugs
Company: RISING PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MYCOPHENOLATE MOFETIL HYDROCHLORIDE | MYCOPHENOLATE MOFETIL HYDROCHLORIDE | 500MG/VIAL | 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 |
---|---|---|---|---|---|---|---|
02/28/2017 | 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 |
---|---|---|---|---|---|
08/13/2024 | SUPPL-16 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
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07/03/2024 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
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07/03/2024 | SUPPL-14 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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08/11/2021 | SUPPL-11 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
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04/21/2021 | SUPPL-9 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
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01/15/2021 | SUPPL-8 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
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07/03/2024 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
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11/27/2019 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
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11/27/2019 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
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11/27/2019 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
MYCOPHENOLATE MOFETIL HYDROCHLORIDE
INJECTABLE;INJECTION; 500MG/VIAL
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CELLCEPT | MYCOPHENOLATE MOFETIL HYDROCHLORIDE | 500MG/VIAL | INJECTABLE;INJECTION | Prescription | Yes | AP | 050758 | ROCHE PALO |
MYCOPHENOLATE MOFETIL HYDROCHLORIDE | MYCOPHENOLATE MOFETIL HYDROCHLORIDE | 500MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 214283 | BPI LABS |
MYCOPHENOLATE MOFETIL HYDROCHLORIDE | MYCOPHENOLATE MOFETIL HYDROCHLORIDE | 500MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 203575 | ENDO OPERATIONS |
MYCOPHENOLATE MOFETIL HYDROCHLORIDE | MYCOPHENOLATE MOFETIL HYDROCHLORIDE | 500MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 212130 | MEITHEAL |
MYCOPHENOLATE MOFETIL HYDROCHLORIDE | MYCOPHENOLATE MOFETIL HYDROCHLORIDE | 500MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 203859 | MYLAN LABS LTD |
MYCOPHENOLATE MOFETIL HYDROCHLORIDE | MYCOPHENOLATE MOFETIL HYDROCHLORIDE | 500MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 204043 | RISING PHARMA |
MYCOPHENOLATE MOFETIL HYDROCHLORIDE | MYCOPHENOLATE MOFETIL HYDROCHLORIDE | 500MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 216390 | STERISCIENCE SPECLTS |
MYCOPHENOLATE MOFETIL HYDROCHLORIDE | MYCOPHENOLATE MOFETIL HYDROCHLORIDE | 500MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 204473 | ZYDUS PHARMS |