Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 203895
Company: EUGIA PHARMA
Company: EUGIA PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE;INJECTION | Prescription | AP | No | No |
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE;INJECTION | Prescription | AP | No | No |
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE | BUPIVACAINE HYDROCHLORIDE | 0.75% | 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 |
---|---|---|---|---|---|---|---|
11/05/2013 | 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 |
---|---|---|---|---|---|
08/02/2023 | SUPPL-10 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
03/10/2023 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
07/09/2019 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE
INJECTABLE;INJECTION; 0.25%
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BUPIVACAINE HYDROCHLORIDE | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE;INJECTION | Prescription | No | AP | 217821 | ASPIRO |
BUPIVACAINE HYDROCHLORIDE | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE;INJECTION | Prescription | No | AP | 207183 | EUGIA PHARMA |
BUPIVACAINE HYDROCHLORIDE | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE;INJECTION | Prescription | No | AP | 205141 | HIKMA PHARMS |
BUPIVACAINE HYDROCHLORIDE | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE;INJECTION | Prescription | No | AP | 070583 | HOSPIRA |
BUPIVACAINE HYDROCHLORIDE | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE;INJECTION | Prescription | No | AP | 070590 | HOSPIRA |
BUPIVACAINE HYDROCHLORIDE | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE;INJECTION | Prescription | No | AP | 216039 | MEITHEAL |
BUPIVACAINE HYDROCHLORIDE | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE;INJECTION | Prescription | No | AP | 216040 | MEITHEAL |
BUPIVACAINE HYDROCHLORIDE | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE;INJECTION | Prescription | No | AP | 217792 | SOMERSET |
BUPIVACAINE HYDROCHLORIDE | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE;INJECTION | Prescription | No | AP | 091503 | STERISCIENCE SPECLTS |
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE;INJECTION | Prescription | No | AP | 203895 | EUGIA PHARMA |
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE;INJECTION | Prescription | No | AP | 204842 | HIKMA PHARMS |
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE;INJECTION | Prescription | No | AP | 091487 | STERISCIENCE SPECLTS |
MARCAINE HYDROCHLORIDE | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE;INJECTION | Prescription | Yes | AP | 016964 | HOSPIRA |
MARCAINE HYDROCHLORIDE PRESERVATIVE FREE | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE;INJECTION | Prescription | Yes | AP | 016964 | HOSPIRA |
SENSORCAINE | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE;INJECTION | Prescription | Yes | AP | 018304 | FRESENIUS KABI USA |
SENSORCAINE | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE;INJECTION | Prescription | No | AP | 070552 | FRESENIUS KABI USA |
INJECTABLE;INJECTION; 0.5%
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BUPIVACAINE HYDROCHLORIDE | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE;INJECTION | Prescription | No | AP | 217821 | ASPIRO |
BUPIVACAINE HYDROCHLORIDE | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE;INJECTION | Prescription | No | AP | 207183 | EUGIA PHARMA |
BUPIVACAINE HYDROCHLORIDE | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE;INJECTION | Prescription | No | AP | 205141 | HIKMA PHARMS |
BUPIVACAINE HYDROCHLORIDE | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE;INJECTION | Prescription | No | AP | 070584 | HOSPIRA |
BUPIVACAINE HYDROCHLORIDE | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE;INJECTION | Prescription | No | AP | 070597 | HOSPIRA |
BUPIVACAINE HYDROCHLORIDE | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE;INJECTION | Prescription | No | AP | 070609 | HOSPIRA |
BUPIVACAINE HYDROCHLORIDE | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE;INJECTION | Prescription | No | AP | 216039 | MEITHEAL |
BUPIVACAINE HYDROCHLORIDE | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE;INJECTION | Prescription | No | AP | 216040 | MEITHEAL |
BUPIVACAINE HYDROCHLORIDE | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE;INJECTION | Prescription | No | AP | 217792 | SOMERSET |
BUPIVACAINE HYDROCHLORIDE | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE;INJECTION | Prescription | No | AP | 091503 | STERISCIENCE SPECLTS |
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE;INJECTION | Prescription | No | AP | 203895 | EUGIA PHARMA |
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE;INJECTION | Prescription | No | AP | 204842 | HIKMA PHARMS |
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE;INJECTION | Prescription | No | AP | 091487 | STERISCIENCE SPECLTS |
MARCAINE HYDROCHLORIDE | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE;INJECTION | Prescription | Yes | AP | 016964 | HOSPIRA |
MARCAINE HYDROCHLORIDE PRESERVATIVE FREE | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE;INJECTION | Prescription | Yes | AP | 016964 | HOSPIRA |
SENSORCAINE | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE;INJECTION | Prescription | Yes | AP | 018304 | FRESENIUS KABI USA |
SENSORCAINE | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE;INJECTION | Prescription | No | AP | 070553 | FRESENIUS KABI USA |
INJECTABLE;INJECTION; 0.75%
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BUPIVACAINE HYDROCHLORIDE | BUPIVACAINE HYDROCHLORIDE | 0.75% | INJECTABLE;INJECTION | Prescription | No | AP | 217821 | ASPIRO |
BUPIVACAINE HYDROCHLORIDE | BUPIVACAINE HYDROCHLORIDE | 0.75% | INJECTABLE;INJECTION | Prescription | No | AP | 070585 | HOSPIRA |
BUPIVACAINE HYDROCHLORIDE | BUPIVACAINE HYDROCHLORIDE | 0.75% | INJECTABLE;INJECTION | Prescription | No | AP | 216040 | MEITHEAL |
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE | BUPIVACAINE HYDROCHLORIDE | 0.75% | INJECTABLE;INJECTION | Prescription | No | AP | 203895 | EUGIA PHARMA |
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE | BUPIVACAINE HYDROCHLORIDE | 0.75% | INJECTABLE;INJECTION | Prescription | No | AP | 204842 | HIKMA PHARMS |
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE | BUPIVACAINE HYDROCHLORIDE | 0.75% | INJECTABLE;INJECTION | Prescription | No | AP | 091487 | STERISCIENCE SPECLTS |
MARCAINE HYDROCHLORIDE PRESERVATIVE FREE | BUPIVACAINE HYDROCHLORIDE | 0.75% | INJECTABLE;INJECTION | Prescription | Yes | AP | 016964 | HOSPIRA |
SENSORCAINE | BUPIVACAINE HYDROCHLORIDE | 0.75% | INJECTABLE;INJECTION | Prescription | Yes | AP | 018304 | FRESENIUS KABI USA |
SENSORCAINE | BUPIVACAINE HYDROCHLORIDE | 0.75% | INJECTABLE;INJECTION | Prescription | No | AP | 070554 | FRESENIUS KABI USA |