Drugs@FDA: FDA-Approved Drugs
Company: HIKMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NALOXONE | NALOXONE HYDROCHLORIDE | 0.4MG/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 |
---|---|---|---|---|---|---|---|
10/22/1985 | 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 |
---|---|---|---|---|---|
03/12/2015 | SUPPL-17 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
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09/14/2000 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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01/25/1999 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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01/25/1999 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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09/26/1997 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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08/26/1996 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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11/18/1993 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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07/27/1993 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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03/26/1993 | SUPPL-9 | Labeling |
Label is not available on this site. |
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09/25/1990 | SUPPL-7 | Labeling |
Label is not available on this site. |
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02/22/1990 | SUPPL-6 | Labeling |
Label is not available on this site. |
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07/20/1989 | SUPPL-5 | Labeling |
Label is not available on this site. |
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12/19/1986 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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11/03/1986 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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01/29/1987 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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01/29/1987 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
NALOXONE
INJECTABLE;INJECTION; 0.4MG/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
NALOXONE | NALOXONE HYDROCHLORIDE | 0.4MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 070299 | HIKMA |
NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | 0.4MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 216624 | ACCORD HLTHCARE |
NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | 0.4MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 214785 | BAXTER HLTHCARE CORP |
NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | 0.4MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 214792 | BAXTER HLTHCARE CORP |
NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | 0.4MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 212455 | EUGIA PHARMA |
NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | 0.4MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 212456 | EUGIA PHARMA |
NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | 0.4MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 213573 | FRESENIUS KABI USA |
NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | 0.4MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 212300 | HIKMA |
NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | 0.4MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 070172 | HOSPIRA |
NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | 0.4MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 070256 | HOSPIRA |
NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | 0.4MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 070257 | HOSPIRA |
NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | 0.4MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 218404 | MANKIND PHARMA |
NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | 0.4MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 204997 | MYLAN INSTITUTIONAL |
NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | 0.4MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 205014 | MYLAN INSTITUTIONAL |
NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | 0.4MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 208871 | RISING |
NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | 0.4MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 208872 | RISING |
NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | 0.4MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 207633 | SOMERSET THERAPS LLC |
NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | 0.4MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 207634 | SOMERSET THERAPS LLC |