Drugs@FDA: FDA-Approved Drugs
Company: HIKMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
OXYTOCIN | OXYTOCIN | 10USP UNITS/ML (10USP UNITS/ML) | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
OXYTOCIN | OXYTOCIN | 100USP UNITS/10ML (10USP UNITS/ML) | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
04/29/1980 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/09/2014 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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01/10/2007 | SUPPL-13 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
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03/22/1995 | SUPPL-12 | Labeling |
Label is not available on this site. |
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12/23/1993 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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09/16/1993 | SUPPL-10 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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01/22/1990 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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08/02/1988 | SUPPL-8 | Labeling |
Label is not available on this site. |
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07/14/1987 | SUPPL-7 | Labeling |
Label is not available on this site. |
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09/24/1987 | SUPPL-6 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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07/28/1986 | SUPPL-5 | Labeling |
Label is not available on this site. |
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01/31/1984 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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07/01/1983 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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06/14/1984 | SUPPL-2 | Labeling |
Label is not available on this site. |
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08/14/1980 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
OXYTOCIN
INJECTABLE;INJECTION; 10USP UNITS/ML (10USP UNITS/ML)
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
OXYTOCIN | OXYTOCIN | 10USP UNITS/ML (10USP UNITS/ML) | INJECTABLE;INJECTION | Prescription | Yes | AP | 018248 | FRESENIUS KABI USA |
OXYTOCIN | OXYTOCIN | 10USP UNITS/ML (10USP UNITS/ML) | INJECTABLE;INJECTION | Prescription | Yes | AP | 018243 | HIKMA |
OXYTOCIN | OXYTOCIN | 10USP UNITS/ML (10USP UNITS/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 200219 | HIKMA FARMACEUTICA |
OXYTOCIN | OXYTOCIN | 10USP UNITS/ML (10USP UNITS/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 091676 | SAGENT PHARMS INC |
PITOCIN | OXYTOCIN | 10USP UNITS/ML (10USP UNITS/ML) | INJECTABLE;INJECTION | Prescription | Yes | AP | 018261 | PAR STERILE PRODUCTS |
INJECTABLE;INJECTION; 100USP UNITS/10ML (10USP UNITS/ML)
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
OXYTOCIN | OXYTOCIN | 100USP UNITS/10ML (10USP UNITS/ML) | INJECTABLE;INJECTION | Prescription | Yes | AP | 018248 | FRESENIUS KABI USA |
OXYTOCIN | OXYTOCIN | 100USP UNITS/10ML (10USP UNITS/ML) | INJECTABLE;INJECTION | Prescription | Yes | AP | 018243 | HIKMA |
OXYTOCIN | OXYTOCIN | 100USP UNITS/10ML (10USP UNITS/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 091676 | SAGENT PHARMS INC |
PITOCIN | OXYTOCIN | 100USP UNITS/10ML (10USP UNITS/ML) | INJECTABLE;INJECTION | Prescription | Yes | AP | 018261 | PAR STERILE PRODUCTS |