Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 206560
Company: CADILA
Company: CADILA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
METRONIDAZOLE | METRONIDAZOLE | 250MG | TABLET;ORAL | Prescription | AB | No | No |
METRONIDAZOLE | METRONIDAZOLE | 500MG | TABLET;ORAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
11/16/2016 | ORIG-1 | Approval | 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 |
---|---|---|---|---|---|
08/13/2019 | SUPPL-2 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
METRONIDAZOLE
TABLET;ORAL; 250MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
FLAGYL | METRONIDAZOLE | 250MG | TABLET;ORAL | Prescription | Yes | AB | 012623 | GD SEARLE LLC |
METRONIDAZOLE | METRONIDAZOLE | 250MG | TABLET;ORAL | Prescription | No | AB | 079067 | ALEMBIC PHARMS LTD |
METRONIDAZOLE | METRONIDAZOLE | 250MG | TABLET;ORAL | Prescription | No | AB | 203974 | AUROBINDO PHARMA LTD |
METRONIDAZOLE | METRONIDAZOLE | 250MG | TABLET;ORAL | Prescription | No | AB | 206560 | CADILA |
METRONIDAZOLE | METRONIDAZOLE | 250MG | TABLET;ORAL | Prescription | No | AB | 209794 | CADILA PHARMS LTD |
METRONIDAZOLE | METRONIDAZOLE | 250MG | TABLET;ORAL | Prescription | No | AB | 207309 | FLAMINGO PHARMS |
METRONIDAZOLE | METRONIDAZOLE | 250MG | TABLET;ORAL | Prescription | No | AB | 205245 | HERITAGE PHARMS INC |
METRONIDAZOLE | METRONIDAZOLE | 250MG | TABLET;ORAL | Prescription | No | AB | 070772 | INNOGENIX |
METRONIDAZOLE | METRONIDAZOLE | 250MG | TABLET;ORAL | Prescription | No | AB | 209096 | LUPIN LTD |
METRONIDAZOLE | METRONIDAZOLE | 250MG | TABLET;ORAL | Prescription | No | AB | 208681 | ORIT LABS LLC |
METRONIDAZOLE | METRONIDAZOLE | 250MG | TABLET;ORAL | Prescription | No | AB | 070040 | STRIDES PHARMA |
METRONIDAZOLE | METRONIDAZOLE | 250MG | TABLET;ORAL | Prescription | No | AB | 208162 | STRIDES PHARMA |
METRONIDAZOLE | METRONIDAZOLE | 250MG | TABLET;ORAL | Prescription | No | AB | 070027 | TEVA PHARMS USA |
METRONIDAZOLE | METRONIDAZOLE | 250MG | TABLET;ORAL | Prescription | No | AB | 203458 | UNICHEM LABS LTD |
METRONIDAZOLE | METRONIDAZOLE | 250MG | TABLET;ORAL | Prescription | No | AB | 070035 | WATSON LABS |
TABLET;ORAL; 500MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
FLAGYL | METRONIDAZOLE | 500MG | TABLET;ORAL | Prescription | Yes | AB | 012623 | GD SEARLE LLC |
METRONIDAZOLE | METRONIDAZOLE | 500MG | TABLET;ORAL | Prescription | No | AB | 079067 | ALEMBIC PHARMS LTD |
METRONIDAZOLE | METRONIDAZOLE | 500MG | TABLET;ORAL | Prescription | No | AB | 203974 | AUROBINDO PHARMA LTD |
METRONIDAZOLE | METRONIDAZOLE | 500MG | TABLET;ORAL | Prescription | No | AB | 206560 | CADILA |
METRONIDAZOLE | METRONIDAZOLE | 500MG | TABLET;ORAL | Prescription | No | AB | 209794 | CADILA PHARMS LTD |
METRONIDAZOLE | METRONIDAZOLE | 500MG | TABLET;ORAL | Prescription | No | AB | 207309 | FLAMINGO PHARMS |
METRONIDAZOLE | METRONIDAZOLE | 500MG | TABLET;ORAL | Prescription | No | AB | 205245 | HERITAGE PHARMS INC |
METRONIDAZOLE | METRONIDAZOLE | 500MG | TABLET;ORAL | Prescription | No | AB | 070772 | INNOGENIX |
METRONIDAZOLE | METRONIDAZOLE | 500MG | TABLET;ORAL | Prescription | No | AB | 209096 | LUPIN LTD |
METRONIDAZOLE | METRONIDAZOLE | 500MG | TABLET;ORAL | Prescription | No | AB | 208681 | ORIT LABS LLC |
METRONIDAZOLE | METRONIDAZOLE | 500MG | TABLET;ORAL | Prescription | No | AB | 070033 | PLIVA |
METRONIDAZOLE | METRONIDAZOLE | 500MG | TABLET;ORAL | Prescription | No | AB | 070039 | STRIDES PHARMA |
METRONIDAZOLE | METRONIDAZOLE | 500MG | TABLET;ORAL | Prescription | No | AB | 208162 | STRIDES PHARMA |
METRONIDAZOLE | METRONIDAZOLE | 500MG | TABLET;ORAL | Prescription | No | AB | 203458 | UNICHEM LABS LTD |
METRONIDAZOLE | METRONIDAZOLE | 500MG | TABLET;ORAL | Prescription | No | AB | 070044 | WATSON LABS INC |
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English